Asia–Pacific Consensus Guidelines for Endoscopic ... · Yang Z, Zheng X, Asia–Pacific Consensus...

Accepted Manuscript

Asia–Pacific Consensus Guidelines for Endoscopic Management of Benign BiliaryStrictures

Bing Hu, MD, PhD, Bo Sun, MD, Qiang Cai, MD, PhD, James Yun Wong Lau, MD,Shuren Ma, MD, Takao Itoi, MD, PhD, Jong Ho Moon, MD, PhD, Ichiro Yasuda,MD, PhD, Xiaofeng Zhang, MD, Hsiu-Po Wang, MD, PhD, Shomei Ryozawa, MD,PhD, Rungsun Rerknimitr, MD, Wen Li, MD, Hiromu Kutsumi, MD, PhD, SundeepLakhtakia, MD, Hideyuki Shiomi, MD, PhD, Ming Ji, MD, Xun Li, MD, Dongmei Qian,MD, Zhuo Yang, MD, Xiao Zheng, MD

PII: S0016-5107(17)30174-8

DOI: 10.1016/j.gie.2017.02.031

Reference: YMGE 10443

To appear in: Gastrointestinal Endoscopy

Received Date: 12 December 2016

Accepted Date: 23 February 2017

Please cite this article as: Hu B, Sun B, Cai Q, Wong Lau JY, Ma S, Itoi T, Moon JH, Yasuda I, ZhangX, Wang H-P, Ryozawa S, Rerknimitr R, Li W, Kutsumi H, Lakhtakia S, Shiomi H, Ji M, Li X, Qian D,Yang Z, Zheng X, Asia–Pacific Consensus Guidelines for Endoscopic Management of Benign BiliaryStrictures, Gastrointestinal Endoscopy (2017), doi: 10.1016/j.gie.2017.02.031.

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ACCEPTED MANUSCRIPT

Asia–Pacific Consensus Guidelines for Endoscopic Management of

Benign Biliary Strictures

Short title: International consensus for BBS

Bing Hu, MD, PhD,1 Bo Sun, MD,

1 Qiang Cai, MD, PhD,

2 James Yun Wong Lau, MD,

3 Shuren Ma,

MD,4 Takao Itoi, MD, PhD,

5 Jong Ho Moon, MD, PhD,

6 Ichiro Yasuda, MD, PhD,

7 Xiaofeng Zhang,

MD,8 Hsiu-Po Wang, MD, PhD,

9 Shomei Ryozawa, MD, PhD,

10 Rungsun Rerknimitr, MD,

11 Wen Li,

MD,12

Hiromu Kutsumi, MD, PhD,13

Sundeep Lakhtakia, MD,14

Hideyuki Shiomi, MD, PhD,15

Ming

Ji, MD,16

Xun Li, MD,17

Dongmei Qian, MD,18

Zhuo Yang, MD,4 Xiao Zheng, MD,

1

1 Department of Gastroenterology & Endoscopy, Eastern Hepatobiliary Hospital, Second Military

Medical University, Shanghai, China.

2 Advanced Endoscopy Fellowship, Emory University School of Medicine, Atlanta, USA

3 Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong

Kong, China

4 Endoscopic center, Institute of Minimal Invasive Therapy for Digestive Disease, The General

Hospital of Shenyang Military Region, Shenyang, China

5 Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan

6 Division of Gastroenterology, Digestive Disease Center, Soon Chun Hyang University Bucheon

Hospital, Bucheon, Korea

7 Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan

8 Department of Gastroenterology, Hangzhou First People’s Hospital, Hangzhou, China

9 Endoscopic Division, National Taiwan University Hospital, Taipei, Taiwan

10 Department of Gastroenterology, Saitama Medical University International Medical Center,

Saitama, Japan

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GI Endoscopy Excellence Center, Department of Medicine, Chulalongkorn University, Bangkok,

Thailand

12 Endoscopic Center, Tianjin People’s Hospital, Tianjin, China

13 Center for Clinical Research and Advanced Medicine, Shiga University of Medical Science, Otsu,

Japan

14 Asian Institute of Gastroenterology, Hyderabad, India

15 Division of Gastroenterology, Graduate School of Medicine, Kobe University, Kobe, Japan

16 Department of Gastroenterology, Beijing Friendship Hospital, The Capital Medical University,

Beijing, China

17 Department of General Surgery II, The First Affiliated Hospital, Lanzhou University, Gansu,

China

18 Department of Digestive Diseases, Beijing Tongren Hospital, The Capital Medical University,

Beijing, China

Corresponding author: Bing Hu MD, PhD, Department of Gastroenterology & Endoscopy, Eastern

Hepatobiliary Hospital, Second Military Medical University. Shanghai, China. Email:

[email protected] Tel: 8621-81875221, Fax: 8621-35030072

Specific author contributions:

1. Bing Hu, Bo Sun, Xiao Zheng: conception and design; drafting of initial statements; review,

revision and voting on statements.

2. Qiang Cai, James Yun Wong Lau, Shuren Ma, Takao Itoi, Jong Ho Moon, Ichiro Yasuda,

Xiaofeng Zhang, Hsiu-Po Wang, Shomei Ryozawa, Rungsun Rerknimitr, Wen Li, Hiromu

Kutsumi, Sundeep Lakhtakia, Hideyuki Shiomi, Ming Ji, Xun Li, Dongmei Qian, Zhuo Yang:

review, revision and voting on statements.

3. All authors have approved the final draft submitted.

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ACCEPTED MANUSCRIPTFinancial support: This study was partially supported by the fundings from Shanghai

Outstanding Medical Academic Leader Program (2015-83).

Potential competing interests: None

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Abstract

Benign biliary strictures (BBSs) are commonly caused by surgical injury, chronic

pancreatitis, and inflammatory cholangiopathies. Although advanced imaging tests

and tissue acquisition methods have been developed for evaluation of indeterminate

biliary strictures, differentiation of BBSs from biliary malignancies remains a

challenge to clinicians. The majority of BBSs have good response to nonsurgical

treatment and surgical intervention mainly serves as a rescue when nonsurgical

approaches fail. Endoscopic management is a safe, effective, and less-invasive

treatment for BBSs compared with other approaches. Endoscopic biliary stricture

dilation followed by placement of multiple plastic stents has been the first-line

choice with good long-term ductal patency. Recently, covered self-expanding metal

stents (CSEMSs) has been increasingly used in the management of BBSs with similar

effectiveness but easier deployment, fewer endoscopic sessions compared with

plastic stents. Moreover, other technologies are emerging in the diagnosis and

management of BBSs. To assist clinicians in managing BBSs, the Asia-Pacific ERCP

Club (APEC) has developed this statement through a systematic review of the

literature.

Key words: Consensus statements; benign biliary strictures;

cholangiopancreatography, endoscopic retrograde; stent

Introduction

The primary goal of treatment for benign biliary strictures (BBSs) is to resolve bile

duct obstruction, to achieve a long-term ductal patency and to maintain liver

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function. Endoscopic approach has become the first-line option for most cases of

BBSs. Biliary drainage can be maintained through combination of endoscopic

stricture dilation and biliary stenting. The effectiveness, clinical success, and

outcomes of endoscopic intervention for BBSs largely depend on specific etiologies,

endoscopic techniques used, and the selection of appropriate accessories and stents,

which varies in the literature. New endoscopic techniques have also been developed

to improve the success of endotherapy. Therefore, we established this consensus

recommendation to better assist clinical decision making and standardize

endoscopic techniques in endoscopic management of BBSs.

Methods

A comprehensive literature searching of the PubMed/Medline and EMBASE

databases was conducted for the English language publications on BBSs. Search

items included “benign strictures,” “biliary,” and pertinent to specific statements.

After screening the corresponding abstracts of the retrieved articles, the full text of

the articles relevant to this review were downloaded. Electronic searches were then

supplemented by manual searches of reference of these articles.

Before the consensus meeting, a list of statements was generated by the Chinese

co-authors and were divided into the following topics: diagnosis, pre-procedure

preparation, biliary access, stricture dilation, stenting, alternate therapy, and specific

indications for endoscopic treatment of BBSs including post-liver transplantation,

surgical injury, chronic pancreatitis (CP), primary sclerosing cholangitis (PSC), IgG-4

related sclerosing cholangitis (IgG-4 SC), bilio-enteric anastomotic stricture. B. Hu, B.

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Sun, and X. Zheng wrote the commentaries on all the statements. The draft of

statement was distributed electronically in advance to all consensus members. The

first vote was conducted electronically by e-mail with a response rate of 85% (17/20).

All feedbacks were collected and the draft statement was revised before the

face-to-face meeting.

A face-to-face meeting of all consensus members was held in October 21, 2016, in

Shenyang, Liaoning Province of China. Nineteen of 20 (95%) consensus members

participated in the meeting (S. Lakhtakia didn’t participate but voted through email

again). All statements, commentaries and relevant evidence were reviewed,

discussed, and revised accordingly. The evidence level and recommendation grade

were rated using the grading system developed by the Scottish Intercollegiate

Guidelines Network Grading Review Group (Table 1).1 The voting system used was a

4-point scale (Table 2). The second vote was conducted in this meeting. Consensus

was considered to be achieved when the majority (≥80%) of voting members

indicated “agree completely” or “agree with some reservation.” The final revised

version was approved by all members of the Asia-pacific ERCP Club committee

before publication. All approved statements were enlisted in Table 3.

Consensus statements

GENERAL PRINCIPLES

Etiology

1. BBSs arise from diverse etiologies, most commonly postoperative injury and

chronic inflammation.

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Level of evidence: 2++

Recommendation grade: B

Level of agreement: A, 85%; B, 15%; C, 0%; D, 0%

BBSs have heterogeneous etiologies and are commonly caused by surgical bile duct

injury, chronic pancreatitis and chronic cholangiopathy (eg, primary or secondary

sclerosing cholangitis) (table 4). Cholecystectomy and liver transplantation (LT) are

the most common etiologies of surgical related biliary strictures. The reported

incidence of post-LT biliary strictures is approximately 10% to 40% with anastomotic

biliary strictures (ABS) the most common adverse event. 2, 3

Cholecystectomy is

another important etiology of BBSs, which is mostly caused by direct bile duct injury

during surgery. The incidence of post-cholecystectomy biliary stricture is

approximately 0.5% which has not been influenced by the increasing experience

with laparoscopy.4 Among the non-surgical etiologies, chronic pancreatitis

associated biliary strictures normally occur in the distal common bile duct and tends

to be refractory due to fibrosis and calcification of periductal tissue. A multi-center

survey covering a 10-year period of 2008 Chinese patients with chronic pancreatitis

showed that biliary strictures developed in 13.4% of study patients.5 Due to the

diversity of etiologies, the effectiveness of treatment for BBSs is not uniform. The

clinical presentation of BBSs is related directly to the degree and onset of biliary

obstruction, and ranges from asymptomatic to severe or even life-threatening

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condition. The outcome also varies and depends on the etiology, pathogenesis, and

response to treatment.

Diagnosis

2. The diagnosis of BBS should be made carefully by the combination of history

review, cross-section imaging studies and endoscopic procedures. Histological

diagnosis by cytology or biopsy, as well as long-term clinical follow-up are

recommended to confirm the diagnosis.

Level of evidence: 1+

Recommendation grade: A


Diagnosis of biliary strictures remains a clinical challenge due to either the risk of

missing resectable malignancy or the expenditure and morbidity related to

unnecessary operation in patients with benign etiologies.6 A multidisciplinary

approach is required to confirm the diagnosis, which includes history review, basic

laboratory work-ups, cross-section abdominal imaging, and other advanced

intraductal imaging tests. Taking a thorough clinical history into consideration may

be beneficial in clarifying the etiology of a biliary stricture.7 Typical etiologies of

benign strictures are listed in Table 4. Cross-section imaging tests and EUS are

preferred initial investigation for biliary strictures, whereas ERCP-directed tissue

acquisition and EUS-guided fine-needle aspiration or biopsy are the only way to

provide cytohistological diagnosis. ERCP-guided brushing cytology and/or

transpapillary forceps biopsy (TPFB) is widely applied with high specificity, but low

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sensitivity in diagnosing biliary strictures. A recent meta-analysis showed that the

pooled sensitivity and specificity for the diagnosis of malignant biliary strictures were

45% and 99% for brushing cytology, and 48.1% and 99.2% for TPFB.8 Therefore,

other technologies have been applied to improve the diagnosis when brush cytology

and TPFB are indeterminate, which include, but not limited to, Fluorescent in-situ

hybridization (FISH) , EUS-FNA, intraductal ultrasound (IDUS), per-oral

cholangioscopy and confocal laser endomicroscopy.9, 10

In addition, clinical follow-up

of at least 6 months with a benign clinical course is required to support a benign

stricture. This is supported by a prospective single center, long-term (182.8

person-years) follow-up study involving 104 patients with indeterminate biliary

strictures, in which the detection of biliary cancer was more common during the first

6 months of follow-up.11

Long-term follow-up is also mandatory in those with risk of

developing malignancy, such as PSC.12

3. Non-invasive imagings such as MRCP and/or MD-CT are necessary before ERCP

procedure, as it can provide useful roadmap and clarify the preprocedure plan.




Abdominal imaging tests are widely used in patients with biliary obstruction, such as

magnetic resonance imaging (MRI), computed tomography (CT), and

trans-abdominal US. MRCP has been increasingly used as a noninvasive alternative

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to ERCP, which provides high-quality imaging information of biliary tree just as

radiocontrast cholangiography and allows pre-ERCP evaluation of biliary strictures

with regard to the location, stricture margin, and length. On MRCP, a BBS is

characterized by regular, symmetric and short-segment narrowing, whereas

malignant strictures usually present with irregular, asymmetric, and long-segment

narrowing, particularly ≥14 mm in length.13

A randomized clinical trial showed that

MRCP has a comparable accuracy with ERCP in differentiating extrahepatic

cholangiocarcinoma (CCA) from benign strictures, and a strategy of pre-ERCP MRCP

decreased the need for subsequent ERCPs in patients with suspected biliary

obstruction.14

Meta-analysis demonstrated that MRCP has a high sensitivity and

specificity for evaluation of post-LT biliary strictures.15

When noninvasive imaging

tests fail to identify the cause of biliary strictures, EUS, when available, can be

performed before ERCP in a single session and is useful to provide more diagnostic

information.16

As a result, we believe MRCP, as well as other non-invasive or less

invasive diagnostic modalities should be selected for the initial evaluation of patients

with biliary strictures before ERCP procedure.

Role of endotherapy

4. ERCP is the first-line interventional option for the management of most BBS

patients with accessible papilla.


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The goal of treatment for BBSs is to obtain a long-term bile duct patency through

surgical or non-surgical approaches (eg, endoscopic and/or percutaneous

intervention).Long-term follow-up study revealed that endoscopic therapy for BBSs

is safe, effective, less-invasive, and repeatable.17

Therefore, it has become the first

therapeutic choice for relieving bile duct obstruction in most cases of BBSs. Standard

endoscopic techniques include stricture dilation with balloon or bougie catheter

followed by insertion of multiple plastic stents. Plastic stents are required to be

exchanged periodically for up to 12 months to maintain ductal patency. Placement

of fully covered self-expanding metal stent (FCSEMS) is becoming an accepted

method for BBSs given its safety, high success rate, easier insertion technique, and

requiring fewer endoscopic sessions.18, 19

In a large prospective multinational study

of 177 patients with BBSs received FCDEMS by Deviere, et al, endoscopic removal of

FCSEMS was achieved in all 131 patients who were shceduled for stent removal, 94.7%

(124/131) of whom had no removal related serious adverse events, and stricture

resolution were achieved in 135 patients (76.3%).20

In addition, FCSEMSs have been

established as an alternative therapy to plastic stents for BBSs or stands as a rescue

therapy when multiple plastic stents failed. In a prospective study, placement of

FCSEMS for 6 months achieved stricture resolution in 70.6% (12/17) of patients who

had CBD strictures secondary to chronic pancreatitis and were not respond to single

10F plastic stent placement. Eight patients completed a 2-year follow-up without

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stricture recurrence.21

Percutaneous biliary interventions are reserved for patients

with surgically altered anatomy or inaccessible papilla (eg, history of Roux-en-Y

gastric bypass and biliary-enteric anastomosis), who are not candidates for

endoscopic intervention.22

Finally, surgical technique plays a role in the setting of

bile duct dissection or unsuccessful endoscopic and percutaneous intervention.

Preparation

5. Prophylactic antibiotics should be administered in selected patients, such as

those with complex hilar strictures, post liver transplantation and PSC.




Cholangitis and sepsis are known adverse events of ERCP. ERCP in patients with

biliary strictures has been associated with a higher rate of bacteremia than in those

without bile duct obstruction. Traditionally, use of prophylactic antibiotics before the

procedure has been administered to reduce the incidence of ERCP-related infective

adverse events. However, an early meta-analysis of 5 randomized, controlled trials

revealed that prophylactic antibiotics before ERCP procedures could not significantly

reduce the incidence of cholangitis and bacteremia.23

This has been further

supported by another recent meta-analysis of 7 clinical trials with 1389 patients,

which concluded that prophylactic antibiotics were not effective to prevent

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ERCP-induced cholangitis in unselected patients.24

Therefore, antibiotics cannot be

routinely recommended to prevent ERCP-induced cholangitis in unselected patients.

However, increased risk of post-procedure infection has been associated with

incomplete biliary drainage, which is commonly seen in post-liver transplantation

biliary strictures and PSC due to complex or multiple biliary strictures.25

A longer

duration of procedures with multiple intraductal manipulations such as brush

cytology, forceps biopsies, balloon dilation and intraductal cholangioscopy/US

examination could also contribute to a higher incidence of post-ERCP cholangitis in

PSC patients than non-PSC patients.26

Therefore, antibiotic prophylaxis is

recommended in the setting of biliary obstruction and anticipated incomplete biliary

drainage. However, adequate drainage of the biliary obstruction is fundamental to

reduce post-ERCP cholangitis.27

Antibiotics that cover biliary flora, such as enteric

gram-negative organisms, enterococci, and pseudomonas, are recommended.28

Biliary access

6. Negotiating the biliary stricture with guidewire requires reasonable skill from

endoscopist and assistant, and use of appropriate catheter and guidewire.

Level of evidence: 4

Recommendation grade: D


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Success deep biliary cannulation with guidewire is critical in maintaining biliary

access and is prerequisite for therapeutic ERCP. In cases of difficult bile duct

cannulation, various techniques have been developed and are effective to facilitate

selective biliary cannulation, such as early precut fistulotomy, double-guidewire

cannulation method, wire-guided cannulation over a pancreatic stent, and precut

after placement of a pancreatic stent .29, 30

However, attempts at guidewire passage

beyond the BBS is still challenging depending on the severity and anatomic location

of obstruction. Although there exists a paucity of comparative studies to guide the

best choice of guidewire,31

standard 0.035-inch hydrophilic guidewires are most

commonly used to traverse a stricture. In severe and complex strictures, specialized

guidewires with smaller diameter and better maneuverability (eg, 0.025, 0.021, and

0.018-inch) with or without an angulated tip may be required. Additionally, when

conventional methods fail to achieve guidewire passage of BBSs, other techniques,

such as inflated balloon extraction, Spyglass cholangioscopy-assisted guidewire

placement, may be required.32

Nevertheless, forceful maneuvers should be avoided

to prevent the creation of a false tract or biliary perforation.

Dilation

7. Serial incremental (balloon or bougie catheter) dilation is usually necessary for

the management of severe BBSs, but particular caution should be taken during

early postoperative period.

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Serial incremental endoscopic dilation followed by multiple plastic stent placement

is often required for benign, severe fibrotic biliary strictures. Either balloon dilators

or bougie-like tapered catheter can be used but balloon dilation is often needed in

tight strictures. The dilating balloon is advanced over a guidewire across the stricture

under fluoroscopic guidance, and is suggested to be maintained fully inflated for 30

to 60s, or until the stricture waist disappears under fluoroscopy. However, forceful

dilation of an early post-operative stricture (<4 weeks after surgery) should be

avoided to reduce the risk of dehiscence of bile duct and resultant bile leak. 33

Moreover, early postoperative bile duct strictures often accompanied with bile leaks,

in which circumstances aggressive dilation of the stricture should also be avoided.

8. Balloon dilation alone, without subsequent stenting, is associated with a high

rate of BBS recurrence.




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Balloon dilation followed by biliary stent placement is a widely applied strategy in

management of most types of BBSs with excellent long-term outcomes.17, 34

Balloon

dilation alone of post-liver transplant anastomotic strictures (PLTASs) showed a high

recurrence rate whereas single or multiple stents insertion after initial balloon

dilation could maintain ductal patency.33

A recent systematic review of 19 studies

concluded that longer stenting duration for PLTASs predicted less recurrence

(OR=0.95, P=0.002). The pooled stricture resolution rate was 86% in 18 studies using

plastic stents and the pooled recurrence rate was 9%.35

In those with biliary

strictures secondary to chronic pancreatitis, biliary dilation followed by multiple 10F

plastic stents placement with regular stent exchange for 12 months resulted in

stricture resolution in up to 90% of patients.36

Another recent systematic review of

25 studies showed that treatment with covered self-expanding metal stents

achieved a better treatment success rate (77%) at 12-month follow-up than multiple

plastic stents (33%) in 946 patients with biliary strictures associated with CP.37

The

only exception is PSC related strictures, in which dilation alone appeared effective

and no additional benefit was observed in those undergoing stricture dilation and

stenting. 38

Repeated endoscopic balloon dilations of dominant strictures in PSC

patients has been associated with a good long-term outcome.39

Stenting

9. To place multiple plastic stents side-by-side for up to 1 year, using the strategy

of either several sessions with an increasing number of stents or one session

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with maximal stents, has become current standard of care for the majority of

BBSs.




To maintain a long-term patency of bile duct is the major goal in the management of

BBSs. Placement of multiple, large-bore plastic stents side-by-side across the

stricture after stricture dilation has been established as a standard treatment for

BBSs, whose long-term outcomes may be equivalent or superior to surgical

management but with less morbidity.40

This strategy is suitable for patients with

non-hilar extrahepatic BBSs, who have available endoscopic access to the duodenum

and accept multiple endoscopic procedures.41, 42

A systematic review of 47 trials with

1116 patients found that multiple plastic stent placement had a higher overall

clinical success rate (94.3%) and less adverse events (20.3%) compared with

placement of a single plastic stent in the management of BBSs.40

Stents are

exchanged tri-monthly with increasing number and/or diameter of stents for up to

12 months.36, 43

An alternative strategy is by insertion of maximal stents over a single

session, which may lessen the need for frequent stent exchange.44, 45

Symptomatic

stent occlusion rates appeared similar between patients with indwelling multiple

plastic stents undergoing exchange within 6 months and those exchanged more than

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6 months after placement. 46

10. Placement of uncovered SEMS in patients with BBS or indeterminate biliary

stricture is strongly discouraged.




Placement of covered SEMSs is technically easy, which could prevent tissue ingrowth

or stent embedment and is easy to be removed from the bile duct after successful

treatment in most patients with BBSs.47

In contrast to fully covered SEMSs, ingrowth

of reactive tissue occurs through the mesh of uncovered or partially covered SEMSs

after being deployed for a certain period, which may eventually cause stent

embedment, making it unable to be removed endoscopically. Although a

stent-in-stent technique has been recently reported to help retrieve uncovered

SEMSs in case series,48

uncovered SEMS placement is not recommended for treating

BBSs and indeterminate biliary strictures.

11. Placement of fully covered SEMSs has similar successful outcome to that of

multiple plastic stents therapy, but requires fewer endoscopic sessions and

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shorter stenting duration in BBSs such as post-liver transplantation anastomotic

biliary stricture.




Covered SEMS placement is a promising alternative therapy to multiple plastic stents

(MPSs) for selected benign CBD strictures. 49

Despite the higher expenditure of

SEMSs, placement of a CSEMS that opens to a diameter of 10 mm is technically

easier than insertion of MPSs side by side to obtain a comparable diameter of bile

duct dilation. 50, 51

A randomized trial comparing FCSEMS with MPS in post-liver

transplantation anastomotic biliary strictures showed a higher successful stricture

resolution rate (81%-92% vs 76%-90%), shorter median stent dwelling time (3.8 vs

10.1 months), fewer median ERCP sessions (2.0 vs 4.5), and lower adverse event rate

(10% vs 50%) in the FCSEMS group compared with the MPS group. The cost of stent

therapy was lower in the FCSEMS arm than in the MPS group. When post-protocol

consumption was added, the FCSEMS arm was still more cost-effective than the MPS

arm.52

Similar result has been proven in a recently published multicenter RCT

study.53

Therefore, FCSEMS placement is proved as the more patient-friendly and

cost-effective strategy, and achieves similar stricture resolution rate to conventional

MPS, with fewer procedures and procedure-related adverse events.40, 54-56

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Considering that hilar strictures have a relatively poor response to endoscopic

stenting, and CSEMS crossing hilar bifurcation may prevent bile drainage of

non-stenting hepatic lobe, CSEMS therapy can only be recommended as

management of choice for non-hilar BBSs.57,58-64

Cholecystitis is another concern

when placement of FCSEMS in patients with BBSs and gallbladder in situ.67,69

The

optimal duration of stenting with CSEMSs has not been determined. Recently

published study results suggested that post-LT anastomotic biliary strictures can be

successfully managed with FCSEMS with stent dwell time of around 6 months (Table

5), but it takes longer time to remove FCSEMS in chronic pancreatitis or

cholecystectomy associated biliary strictures.47

The treatment success of benign

distal biliary strictures with FCSEMS placement can be compromised by high stent

dislocation rates.74

On the other hand, long time of stent indwelling is associated

with cholangitis resulting from stent occlusion or migration, and may cause difficult

stent removal due to mucosal hyperplasia on the extremities of the SEMS.65, 66

Removal success of FCSEMS appeared less frequent in post-cholecystectomy biliary

strictures than in chronic pancreatitis.47

12. To improve the effectiveness of FCSEMS therapy, efforts should be attempted to

prevent stent migration.


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Compared with uncovered or partially covered SEMSs, FCSEMSs can efficiently

prevent the ingrowth of reactive tissue and stent embedment. However, stent

migration is frequently encountered, which could compromise the effectiveness of

treatment and may cause serious adverse events.20, 60, 64

Meanwhile, enough stent

indwelling period and absence of stent migration have been related to stricture

resolution in patients with BBSs treated by FCSEMS.71

In order to prevent stent

migration, several anti-migration features have been designed. Insertion of a

double-pigtail stent within FCSEMS for anchoring appeared as a simple, safe, and

effective strategy with significantly lower stent migration rate and longer stent

dwelling time compared with FCSEMS alone.72

A newly designed FCSEMS with novel

anchoring flap at the proximal portion of the stent was associated with a much lower

stent migration rate than stents with a flared end (0% vs 33%, P = 0.004).73

An

anatomy-shaped design of FCSMS also appeared effective to reduce the stent

migration rate.74

Percutaneous intervention

13. Percutaneous approach may be useful in case of failed ERCP for “rendezvous”

techniques and in patients with surgically alerted anatomy and inaccessible

papilla

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ERCP is a feasible first choice in the management of BBSs. However, endoscopic

access to the major papilla can be failed in patients with gastric outlet obstruction,

duodenal indwelling stents, or surgically altered anatomy such as Roux-en-Y

hepaticojejunostomy. In these circumstances, percutaneous transhepatic biliary

drainage (PTBD) usually is considered as an alternative treatment for biliary

decompression and to avoid invasive surgical management.75

PTBD followed by

balloon dilation is a minimally invasive, safe, and effective option offering the patient

a quicker recovery and far less morbidity than surgery.76

Prospective data showed

that percutaneous catheter placement in extrahepatic, single-site biliary stricture for

6 to 8 months, with progressive catheter insertion upsizing to 18F to 20F was

effective and achieved stricture resolution in 64% of patients with post-liver

transplantation biliary strictures and in 86.4% of patients with BBSs caused by other

etiologies.77

Percutaneous transhepatic placement of retrievable covered metal

stents also appeared feasible for the treatment of BBSs with satisfied short or

mid-term outcomes.75

Surgical intervention

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14. Surgery is a valid option in cases of complete transection or ligation of bile duct,

in selected patients with unsuccessful to ERCP therapy.




Complete transection or ligation of biliary tract is a serious adverse event of

hepatobiliary surgery due to inadequate visualization of anatomical features in the

surgical field and/or insufficiency of surgeon experience.,78

Endoscopic therapy or

percutaneous treatment is generally ineffective to re-establish physical biliary

drainage when bile duct is completely obstructed or ligated, and surgical repair will

be required. Surgical intervention is also indicated in patients with refractory BBSs or

in those who are not compliant to endoscopic management. This can be particularly

encountered in patients with chronic pancreatitis or post-LT non-anastomotic

strictures. A prospective follow-up study found that patients with chronic

pancreatitis, who have calcifications in the head of pancreas, having a 17-fold

increased risk of failure to standard endoscopic management.79

These patients may

ultimately need surgical treatment which was reported having better long-term

outcomes, and similar treatment success rate compared with endoscopic

intervention for biliary strictures caused by chronic pancreatitis.80

Similarly,

endoscopic drainage has a lower success rates in patients with post-liver

transplantation non-anastomotic strictures than in those with anastomotic strictures,

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and some may eventually require re-transplantation. 81

Innovative techniques

15. Novel techniques, such as magnetic compression anastomosis, intraductal

bipolar radiofrequency ablation & biodegradable biliary stenting, may have

potential role in selected cases when conventional endoscopic and percutaneous

approaches are not successful.




Conventional endoscopic or percutaneous interventions may fail to achieve

successful biliary drainage in severe BBSs. Other novel techniques, such as magnetic

compression anastomosis (MCA), have been developed as rescue methods which

appeared effective and safe in case reports or series.82-85

In a recent case series by

Jang, et al., MCA achieved biliary recanalization in 89.7% (35/39) of patients with

complete postoperative or traumatic biliary obstruction. Adverse events only

occurred in 1 patient with mild cholangitis, and restenosis occurred in 2 patients

during a mean follow-up of 41.8 months.83

A smaller magnet (2.4mm in diameter)

has also been developed recently to facilitate the deployment and appeared

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excellent results in treating complete post-liver transplantation BBSs.82

Hu et al

applied intraductal bipolar radiofrequency ablation with or without biliary stenting in

9 patients with refractory BBSs. Immediate stricture improvement was achieved in all

patients without significant adverse events, and only 1 patient developed restenosis

during a median follow-up of 12.6 months.86

Mauri et al reported using

biodegradable biliary stent to treat refractory postsurgical biliary strictures. Strictures

were resolved in all 10 patients without restenosis during a median follow-up of 16.5

months.87

These novel techniques are promising in the future management of BBSs,

especially when conventional non-surgical methods failed. However, more

large-scale and randomized studies are warranted to further confirm their efficacy

and safety, as well as long-term outcome.

BBS WITH SPECIFIC DISORDERS

Post-LT

16. ERCP therapy is the first-line management approach for the patients with

anastomotic biliary stricture (ABS) and localized non-anastomotic biliary stricture

(NABS). Earlier intervention provides better response.




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Biliary stricture is one of the common adverse events after liver transplantation with

an incidence rate reported of 4% to 43%.88

Post-LT biliary strictures are classified as

ABS or NABS. ABS occurs at the biliary anastomotic site, which is usually single and

more commonly associated with living donor LT than deceased donor LT.2 Endoscopic

treatment is effective and has been established as a first-line therapy for ABSs.

Retrospective studies showed that endoscopic stricture dilation followed by multiple

plastic stent placement achieved a high stricture resolution rate ranging from 66.7%

to 100% in the management of ABS.2, 44, 89, 90

In recent years, covered SEMS has been

increasingly used in ABSs. A small scale, prospective, randomized, multi-center study

showed a sustained stricture resolution in 52% of ABS patients by temporary

placement of partially CSEMSs.91

Another small, prospective, randomized trial

revealed that fully CSEMSs achieved a comparable stricture resolution rate but

reduced number of ERCPs compared with MPS insertion.52

However, ABSs presenting

beyond 6 months after LT needed more episodes of ERCP therapy than those

presenting within 6 months after LT.92

NABSs are located at least 5 mm proximal to the anastomosis and are characterized

by multiple intra-or extrahepatic bile duct strictures with recurrent biliary sludge or

cast formation. Late-onset NABSs (presented 1 year after LT) are more likely seen at

the peripheral branched biliary tree compared with early onset NABSs (within 1

year).93

Compared with ABS, NABSs are often associated with ischemic events, which

are more resistant to endotherapy. Endoscopic management of NABSs, especially in

late-onset NABSs, is more challenging, which features repeated stricture dilation,

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longer period of stenting, a lower success rate ranging from 40% to 81.8%, and a

higher stricture recurrence rate.94, 95

Surgical injury

17. Endoscopic therapy with biliary stenting is an effective approach for

post-operative bile duct stricture with successful long-term outcome

comparable with surgical repair.


Recommendation grade: C


Cholecystectomy has been associated with a 0.5% incidence of bile duct injury. 4

Surgery is considered the treatment of choice for post-cholecystectomy bile duct

strictures (PCBDSs), particularly in patients with total biliary obstruction.96

Endoscopic dilation of postoperative biliary strictures followed by placement of

multiple large-bore plastic stents with trimonthly exchange for a 1-year period has

become an alternative treatment strategy (table 6).42, 96-98

Retrospective studies

showed a similar treatment success rate between surgery and endotherapy for

PCBDS.96, 99

In an early study, Davids et al retrospectively compared endoscopic

stenting (66 patients) with surgical therapy (35 patients) in the management of BBSs.

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Excellent and good result was achieved in 83% in both surgically (mean follow-up of

50 months) and endoscopically treated patients (mean follow-up of 42months after

stent removal). Compared with the surgery group, endoscopically treated patients

featured a less early adverse event (8% vs 26%, p<0.03), but higher late adverse

events (27% vs 0%). Stricture recurrence occurred in 17% of patients in both surgical

and endoscopic groups.99

In another retrospective study by Tocchi et al, a total of 42

patients with PCBDS underwent endoscopic stenting (20) or surgical biliary-digestive

reconstruction (22). Excellent and good outcomes were achieved in 77.3% (17/22) in

the surgery group and in 80% (16/20) in endoscopically treated patients during a

follow-up longer than 60 months. Morbidity occurred more frequently in patients

treated with endoscopic stenting (9 vs 2; p=0.34).

Chronic pancreatitis

18. Fully covered SEMS therapy is associated with optimal resolution rate in BBSs

caused by chronic pancreatitis.




Chronic pancreatitis is frequently associated with CBD strictures that require

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endoscopic or surgical intervention. Endoscopic therapy is less invasive than surgery,

and therefore is the preferred initial management for CP-related CBD strictures when

malignancy can be excluded.100, 101

However, CP-related CBD strictures are more

difficult to treat endoscopically compared with other types of BBSs, particularly in

patients with calcific CP.101 Biliary stenting with multiple plastic stents has been

recommended to relieve biliary obstruction, but covered SEMSs are being

increasingly used in the management of CP-related distal bile duct strictures due to

their larger diameter and the lesser number of therapeutic ERCP sessions.21, 102

Systematic review and meta-analysis of the literature showed that CSEMSs achieved

a higher success rate (77%) than multiple plastic stents (30%) at 12-month follow-up

in resolving CP-related biliary strictures. The median number of ERCP interventions

with CSEMSs was significantly lower than multiple plastic stents (1.5 vs 3.9,

P=0.002).37

In a recent prospective, multicenter, randomized study, Haapamaki et al,

compared the effectiveness of single CSEMS with multiple plastic stents in 60

patients with CP-related CBD strictures. Patients were randomized to receive either a

single 10 mm CSEMS or three 10F plastic stents initially. Another three 10F plastic

stents were added to patients in plastic stent group at 3 months and all stents were

removed at 6 months. The 2-year stricture free success rates were 92% in the CSEMS

group and 90% in the plastic stent group (P=0.405). There was no significant

difference with regard to stent migration rates between plastic stent group and

CSEMS group.67

These results support CSEMSs as an effective therapy in CP setting

with high long-term stricture resolution. Nevertheless, patients with chronic

pancreatitis and significant calcification in the head of pancreas have an increased

risk of not responding to endoscopic therapy, which may ultimately require surgical

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management.

PSC

19. Differentiating benign strictures from CCA in PSC patients is crucial but

challenging.




PSC is associated with an increased risk of CCA. However, early diagnosis of dysplastic

change and localized CCA is difficult. Meta-analysis showed that endoscopic

transpapillary brush cytology has a high specificity of 97% but a modest sensitivity of

43% for detecting CCA in patients with PSC.103

As a result, advanced cytological and

newer endoscopic techniques such as cholangioscopy with biopsy, brush cytology

with fluorescence in situ hybridization (FISH) and probe-based confocal laser

endomicroscopy (pCLE) have been used and are likely to improve the sensitivity for

the diagnosis of malignant biliary change. FISH is currently recommended with

transpapillary tissue sampling to differentiate benign dominant strictures from

malignancies, especially in patients with suspicious or atypical cytological

diagnosis.104

The pooled sensitivity and specificity of FISH for diagnosis of CCA in

patients with PSC were reported 68%, and 70%, respectively in meta-analysis.105

Cholangioscopy allows direct visualization of bile duct epithelial change, guides

targeted biopsy of bile duct strictures, may increase diagnostic rate in suspicious

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lesions when combined with narrow-band imaging, and therefore is considered

superior to ERC for detecting malignant bile duct strictures.106

Arnelo et al

prospectively assessed the clinical utility of single-operator per-oral cholangioscopy

(SOPOC) guided sampling of biliary strictures in 47 patients with PSC. Sample quality

was adequate in 98% of cytology brushings and 95% of the mini-forceps biopsies.

The sensitivity, specificity, accuracy and negative predictive value were 33%, 100%,

96%, and 95%, respectively.107

Another recent prospective study showed that SOPOC

acquired adequate samples for cytological and histological diagnosis in 82% and 91%

of patients, respectively.108

In addition, pCLE can be used with cholangioscopy to

visualize biliary epithelium. Limited data suggest that pCLE may have a high

sensitivity and negative predictive value to exclude neoplasia in patients with PSC.109

20. ERCP intervention is recommended for symptomatic PSC patient with dominant

stricture by balloon or bougie catheter dilation without or with short-term stent

placement.




PSC is characterized by progressive fibrotic inflammation and multifocal strictures of

biliary tree leading to jaundice, cholangitis, deteriorating liver function and

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decreased long-term survival rate.110

Although the optimal treatment of dominant

bile duct strictures remains unclear due to the lack of randomized controlled trials,

cumulative evidence supports the effectiveness of endoscopic intervention in

symptomatic PSC patients with dominant strictures to relieve the obstruction and

preserve liver function.111, 112

Limited data suggest that repeat endoscopic therapy

could achieve longer survival time than predicted survival time in patients with PSC

and dominant strictures.113

Gotthart et al prospectively evaluated the outcome of

long-term endoscopic treatment in PSC patients. A total of 500 balloon dilations

were performed in 96 patients with dominant biliary strictures and 5 patients

underwent biliary stenting. Long-term follow-up results showed successful

preservation of a functioning CBD in all patients with a 5-year and 10-year survival

free of liver transplantation rate of 81% and 52%, respectively.39

Other long-term

follow-up studies also indicated that repeated endoscopic therapy with balloon

dilation and/or stenting appeared safe with acceptable low adverse event rates

ranging from 1% to 4.3%.39, 110, 114

IgG4-SC

21. For patients with IgG4-related bile duct stricture, ERCP with biliary stenting

maybe unnecessary, unless deep obstructive jaundice or acute cholangitis

occurs.

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Recommendation grade: C


IgG4-associated cholangiopathy is an inflammatory disease that can be associated

with autoimmune pancreatitis as well as other multiple systematic diseases.115

Patients with IgG4-SC can present with obstructive jaundice and intra- or

extra-hepatic biliary strictures that are difficult to discriminate from other benign or

malignant biliary strictures such as PSC and CCA. Moreover, IgG4-SC overlapping with

PSC has also been reported.116

Response to steroid trial is supportive for the

diagnosis of IgG4-SC in suspected patients. A small cohort study of 29 patients with

IgG4-SC suggested that treatment responsiveness could be evaluated in more than

50% of patients by biochemistry and on MRCP or ERC as early as 1 to 2 weeks, but

response was lower in the hilar or intrahepatic lesion.117

Corticosteroids are currently

the mainstay of treatment in patients with confirmed or highly suspicious IgG4-SC

with good response in most patients.118

Immunomodulators and biological therapy

have been also reported effective.119

A prospective study of 23 patients with IgG4-SC

by Sandanayake, et al reported 100% response a rate over 6 weeks of prednisolone

treatment.120

In another prospective study of 24 patients with IgG4-SC conducted by

Bjornsson et al, most patients (18, 75%) were treated with corticosteroids and 8 (33%)

were treated with biliary stenting for a median time of 4 months. Ninety percent

(9/10) of patients with elevated bilirubin improved after treatment and biliary stents

could be removed in all after treatment.121

Biliary drainage is only performed in

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selected cases with significant obstructive jaundice or acute cholangitis as a bridge

therapy before patients having response to corticosteroids.122

Bilio-enteric anastomotic stricture

22. In experienced hands, ERCP using balloon-assisted enteroscopy has acceptable

success and adverse event rate in treating BBS with surgically altered anatomy.




Endoscopic treatment of BBS challenges endoscopists substantially in surgically

altered anatomy such as Roux-en-Y gastric bypass, hepaticojejunostomy, and

Whipple procedure, mostly due to the length of afferent limb, complicated

angulation in anastomosis, and adhesion.123

In the last decade, single- and

double-balloon enteroscopy (SBE, and DBE) have been applied to conquer the long

distance and gain access to the bile duct.124,125

The short type DBE is even more

preferred because of its shorter working length of 152cm which is compatible with

most ERCP catheters. Literature has shown a high overall success rate of balloon

enteroscopy assisted ERCP in surgically altered anatomy with acceptable adverse

event rate. A recent meta-analysis of 15 trials with 461 patients showed that the

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pooled success rates were 80.9% for SBE in reaching the biliary anastomosis or the

papilla, 69.4% for obtaining a cholangiogram, and 61.7% for providing successful

biliary interventions. A total of 32 (6.5%) adverse events occurred in 489 procedures

including pancreatitis (n=11), bleeding (n=1) and perforation (n=4) but nearly half of

enrolled studies reported no adverse events.125

Another systematic review analyzed

23 reports with 697 patients who underwent a total of 945 enteroscopy-assisted

ERCP procedures including anastomotic stricture balloon dilation. The overall ERCP

success rate was 74% and adverse events occurred in 32 procedures (3.4%).126

In a

retrospective study of 32 patients with biliary-enteric strictures, Lee et al reported

balloon dilation alone to be successful in 66% of patients with only 1 (5%) recurrence

over a mean follow-up duration of 13.1 years76

.

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ACCEPTED MANUSCRIPTCancer Cytopathol 2013;121:708-17.

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ACCEPTED MANUSCRIPTbiliary dilation: review and long-term follow-up evaluation. Curr Gastroenterol Rep

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ACCEPTED MANUSCRIPTsurgically altered gastrointestinal anatomy. World J Gastrointest Endosc 2015;7:617-27.

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ACCEPTED MANUSCRIPTTable 1. Definitions for evidence levels and recommendation grades used

1

Levels of evidence

1++ High-quality meta-analysis, systematic reviews of RCTs, or RCTs with a very low risk of

bias

1+ Well conducted meta-analysis, systematic reviews of RCTs, or RCTs with a low risk of bias

1- Meta-analysis, systematic reviews or RCTs with a high risk of bias

2++ High-quality systematic reviews of case-control or cohort studies; high-quality

case-control or cohort studies with a very low risk of confounding, bias, or chance and a

high probability that the relationship is causal

2+ Well-conducted case-control or cohort studies with a low risk of confounding, bias, or

chance and a moderate probability that the relationship is causal

2- Case-control or cohort studies with a high risk of confounding, bias, or chance and a

significant risk that the relationship is not causal

3 Non-analytic studies (eg, case reports or case series)

4 Expert opinion

Grades of recommendations

A At least 1 meta-analysis, systematic review, or RCT rated as 1++ and directly applicable

to the target population or a systematic review of RCTs or a body of evidence consisting

principally of studies rated as 1+ directly applicable to the target population and

demonstrating overall consistency of results

B A body of evidence including studies rated as 2++ directly applicable to the target

population and demonstrating overall consistency of results or extrapolated evidence

from studies rated as 1++ or 1+

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ACCEPTED MANUSCRIPTC A body of evidence including studies rated as 1- or 2+ directly applicable to the target

population and demonstrating overall consistency of results or Extrapolated evidence

from studies rated as 2++

D Evidence level 2-, 3 or 4 or extrapolated evidence from studies rated as 2+

Table 2. Voting on recommendation

A

B

C

D

Completely agree

Agree with some reservation

Disagree with some reservation

Completely disagree

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ACCEPTED MANUSCRIPTTable 3. Summary of statements

Topics Statements

GENERAL PRINCIPLES

Etiology 1.BBSs arise from diverse etiologies, most commonly post-operative injury

and chronic inflammation (evidence level: 2++, recommendation level: B).

Diagnosis 2. The diagnosis of BBS should be made carefully by the combination of

history review, cross-section imaging studies and endoscopic procedures.

Histological diagnosis by cytology or biopsy, as well as long-term clinical

follow-up are recommended to confirm the diagnosis (evidence level: 1+,

recommendation level: A).

3. Non-invasive imagings such as MRCP and/or MD-CT are necessary before

ERCP procedure, as it can provide useful roadmap and clarify the

pre-procedure plan(evidence level: 1++, recommendation level: A)

Role of

endotherapy

4. ERCP is the first-line interventional option for the management of most BBS

patients with accessible papilla (evidence level: 2++,recommendation level: B)

Preparation 5. Prophylactic antibiotics should be administered in selected patients, such as

those with complex hilar strictures, post liver transplantation and PSC

(evidence level: 1++,recommendation level: A)

Biliary access 6. Negotiating the biliary stricture with guidewire requires reasonable skill

from endoscopist & assistant, and use of appropriate catheter and guidewire

(evidence level: 4, recommendation level: D)

Dilation 7. Aggressive (balloon or bougie catheter) dilation is usually necessary for the

management of severe BBSs, but particular caution should be taken during

early post-operative period (evidence level: 4, recommendation level: D).

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ACCEPTED MANUSCRIPT 8. Balloon dilation alone, without subsequent stenting, is associated with a

high rate of BBS recurrence (evidence level: 1++, recommendation level: A).

Stenting 9. To place multiple plastic stents side-by-side for up to 1 year, using strategy

of either several sessions with increasing number of stents or one session with

maximal stents, has become current standard of care for the majority of BBSs

(evidence level: 1++, recommendation level: A).

10. Placement of uncovered SEMS in patients with BBS or indeterminate

biliary stricture is strongly discouraged (evidence level: 4, recommendation

level: D).

11. Placement of fully covered SEMS has similar successful outcome to that of

multiple plastic stents therapy, but requires less endoscopic sessions and

shorter stenting duration in BBSs such as post-liver transplantation

anastomotic biliary stricture (evidence level: 1++, recommendation level: A).

12. To improve the effectiveness of FCSEMS therapy, efforts should be

attempted to prevent stent migration (evidence level: 2++, recommendation

level: B).

Percutaneous

intervention

13. Percutaneous approach may be useful in case of failed ERCP for

“rendezvous” techniques and in patients with surgically alerted anatomy and

inaccessible papilla (evidence level: 2++, recommendation level: B).

Surgical

intervention

14. Surgery is a valid option in cases of complete transection or ligation of bile

duct, in selected patients with unsuccessful to ERCP therapy (evidence level:

2++, recommendation level: B).

Innovative

techniques

15. Novel techniques, such as magnetic compression anastomosis, intraductal

bipolar radiofrequency ablation & biodegradable biliary stenting may have

potential role in selected cases when conventional endoscopic and

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ACCEPTED MANUSCRIPTpercutaneous approaches are not successful (evidence level: 3,

recommendation level: D).

BBS WITH SPECIFIC DISORDERS

Post-LT 16. ERCP therapy is the first-line management approach for the patients with

anastomotic biliary stricture (ABS) and localized non-anastomotic biliary

stricture (NABS). Earlier intervention provides better response (evidence level:

1+, recommendation level: A).

Surgical

injury

17. Endoscopic therapy with biliary stenting is an effective approach for

post-operative bile duct stricture with successful long-term outcome

comparable to surgical repair (evidence level: 2+, recommendation level: C)

Chronic

pancreatitis

18. Fully covered SEMS therapy is associated with optimal resolution rate in

BBSs caused by chronic pancreatitis (evidence level: 1++, recommendation

level: A)

PSC 19. Differentiating benign strictures from CCA in PSC patients is crucial but

challenging (evidence level: 2++, recommendation level: B).

20. ERCP intervention is recommended for symptomatic PSC patient with

dominant stricture by balloon or bougie catheter dilation without or with

short-term stent placement (evidence level: 2++, recommendation level: B).

IgG4-SC 21. For patients with IgG4-related bile duct stricture, ERCP with biliary

stenting maybe unnecessary, unless deep obstructive jaundice or acute

cholangitis occurs (evidence level: 2+, recommendation level: C).

Bilio-enteric

anastomotic

stricture

In experienced hands, ERCP using balloon-assisted enteroscopy has high

successful rate and acceptable adverse event rate in treating BBS with

surgically altered anatomy (evidence level: 1++, recommendation level: A). .

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ACCEPTED MANUSCRIPTTable 4. Etiologies of benign biliary strictures

Categories Etiologies

latrogenic Liver transplantation

Cholecystectomy (open or laparoscopic)

Partial hepatectomy

Bilio-enteric anastomosis

Sphincterotomy

TACE

Radiation therapy

Inflammatory cholangiopathy Acute or chronic pancreatitis of any etiology

Primary or secondary sclerosing cholangitis

IgG4-related cholangiopathy

Eosinophilic cholangiopathy

Ischemia Hypotension

Hepatic artery thrombosis

Others Papillary stenosis

Mirizzi syndrome

Portal biliopathy

Parasitic infection

Trauma

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ACCEPTED MANUSCRIPT Cold injury

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ACCEPTED MANUSCRIPTTable 5. Results of recently published series on endoscopic treatment of benign extrahepatic

biliary strictures with FCSEMSs

Desig

n

No

.

pts

Etiology (%) Stent

dwell

time

(mo)

Stricture

Resolution

(%)

f/u

period

(mo)

Adverse

event rate

(%)

Re (%)

Park et

al.(2016)

19

R 13

4

GS (38.1), CP (35.1),

PS (17.9), O (9)

3.1

(media

n)

77.4

(103/132pts)

32

(media

n)

30.8(M) 25.2

Saxena

et

al.(2015)

65

MC,

R

12

3

AS (6.5), BS (30),CP

(24.3),PLTAS (13),

PSC (7.3), PS

(6.5),ID (6.5),O (8.1)

6.1

(mean)

81 18.5

(mean)

9.7(M),

4.9(SO),4.1(

C), 3.3(Pan)

4.1

Haapama

ki et

al.(2015)

67

MC,P,

RCT

30 CP (100) 6 92 40

(media

n)

7 (M),14

(C), 3.3 (Cy),

6.7

(2/30

pts)

Hu et

al.(2014)

68

P 45 PS (28.9), PLTAS

(66.7), CP (4.4)

8.6

(media

n)

91 18.9

(mean)

2.2(Pan),

2.2(C)

6.7

Kaffes et

al.(2014)

52

MC,P,

RCT

10 PLTAS (100) 3 100 24.5

(media

n)

10(C), 0(M) 30(3/1

0 pts)

Irani et

al.(2014)

69

R 14

5

BEA(8.3), BS

(9.7),CP

(50.3),O(6.2),PLTAS(

6.9), PS(7.6),

PSC(2.8), PST(8.3)

6.5

(media

n)

66

(83/125pts)

3

(media

n)

11.7 (C),3.4

(Pan), 2.1

(M),1.4

(Cy), 2.1

(SP),3.2 (I),

8

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ACCEPTED MANUSCRIPT2.4 (N)

Kahaleh,

et

al.(2013)

49

MC,

R

13

3

PS (12.1), GS (21.1),

CP (33.1), PLTAS

(26.3), O (7.5)

3.2

(mean)

77.6

(76/98pts)

10.5(M),

2(P),

6(SP),3 (SO)

NA

Wagh et

al.(2013)

70

P 23 BS (4.3),

CP(60.9),PLTAS

(17.4), ID (17.4)

6 96

(short-term),

83.3(long

term)

18.8

(media

n)

39 (M),4.3

(SP)

16.7

Tarantino

et

al.(2012)

66

MC,P 62 PLTAS

(61.3),CC(14.5),HR

(6.4),CP (6.4), SC

(4.8),BS(4.8),WP(1.6

)

3.2

(mean)

90.3 15.9

(mean)

24.2 (M) 7.1

(4/56pt

s)

AS: ampullary stenosis, BEA: biliary-enteric anastomotic , BS: biliary stones, C: cholangitis, CC: cholecystectomy,

CP: chronic pancreatitis, Cy: cholecystitis, GS: gallstone, HR: hepatic resection, I: inability to remove, ID: idiopathic,

M: stent migration, MC: multi-center, N: new stricture formation, NA: not addressed, O: others, P: prospective,

Pan: pancreatitis, PLTAS: post-LT anastomotic strictures, PS: post-surgical, PSC: primary sclerosing cholangitits, PST:

post-sphincterotomy, R: retrospective, Re: recurrence, SC: sclerosing cholangitis, SD: standard deviation, SO: stent

occlusion, SP: severe pain required stent removal, WP: whipple procedure

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ACCEPTED MANUSCRIPTTable 6. Endoscopic treatment of postoperative biliary strictures with CSEMS or multiple plastic

stents

Design No.

Pts

*

Location or type

of BBS (%)£

Type of

stent

Duration

of

stenting

Mean

No. of

PS

inserted

Overall

success

rate (%)

Mean

F/U

period

Saxena et

al.(2015)65

MC,R 9 Extrahepatic(not

hilum)

FCSEMS Mean

24.4+/-2.

3 wk

86 (6/7pts) 18.5

mo

Kahaleh et

al.(2013)49

MC, R 133 Distal CBD FCSEMS Mean

95.5+/-4

8.7 d

91.6

(11/12pts)

NA

Tarantino et

al.(2012)66

MC, P 14 Extrahepatic FCSEMS Mean

97.6 d

100 (14/14

pts)

15.9

mo

Tuvignon et

al.(2011)98

MC,

F/U

96 Type

I(6.3),II(68.8), III

(20.8), IV(4.2)

MPS Median

12 mo

1.9+/-0.

89

82.3 6.4+/-3

.8 yr

Costamagna

et

al.(2010)42

SC,

F/U

40 Type I (36),II

(21%), III(17),

IV(19), V(7)

MPS NA NA 88.6* 13.7yr

Kuzela et

al.(2005)97

P, F/U 43 Type I MPS Median

12 mo

3.4+/-0.

6

100 16.0+/-

11.1

mo

F/U; follow-up, MC: multi-center, NA: not addressed, P: prospective, PS: plastic stent, R: retrospective, SC:

single-center

* Postsurgical, not included post-liver transplantation

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ACCEPTED MANUSCRIPT£ Bismuth-lazorthes classification of postsurgical benign biliary strictures

§ Four patients (11.4%) had biliary stricture recurrence and 3 developed CBD stones

# FIve died of unrelated causes

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ACCEPTED MANUSCRIPTAbbreviations used in this paper:

ABS (anastomotic biliary strictures), APEC (Asia-Pacific ERCP Club), BBSs (benign biliary strictures),

CCA (cholangiocarcinoma), CP (chronic pancreatitis), CSEMS (covered self-expanding metal

stents), CT (computed tomography), DBE (double balloon enteroscopy), EUS (Endoscopic

ultrasound), EUS-FNA (EUS-guided fine needle aspiration), FCSEMS (fully covered self-expanding

metal stent), FISH (fluorescent in-situ hybridization) , IDUS (intraductal ultrasound), IgG-4 SC

(IgG-4 related sclerosing cholangitis), LT (liver transplantation), MCA (magnetic compression

anastomosis), MPS (multiple plastic stents), MRI (magnetic resonance imaging), PCBDS

(post-cholecystectomy bile duct strictures), pCLE (probe-based confocal laser endomicroscopy),

PLTASs (post-liver transplant anastomotic strictures), PSC (primary sclerosing cholangitis), PTBD

(percutaneous transhepatic biliary drainage), SBE (single balloon enteroscopy), TPFB

(transpapillary forceps biopsy), US (trans-abdominal ultrasound)

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Asia–Pacific Consensus Guidelines for Endoscopic ... · Yang Z, Zheng X, Asia–Pacific Consensus...

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