EUS- Gallbladder Drainage: is it time to replace percutaneous drainage?
Jessica Widmer, DO1, Juveria Abdullah1, Michel Kahaleh, MD.1
Division of Gastroenterology and Hepatology, Department of Medicine, Weill Cornell
Medical College,1 New York, USA
Running title: EUS guided gallbladder drainage
Keywords: Endoscopic ultrasound, Therapeutic Endoscopy, EUS-guided drainage,
EUS-guided intervention. Cholecystoduodenostomy
Address for Correspondence:
Michel Kahaleh, MD, AGAF, FACG, FASGE
Professor of Medicine
Chief of Endoscopy
Division of Gastroenterology & Hepatology
Department of Medicine
Weill Cornell Medical College
1305 York Avenue, 4th Floor
New York, NY 10021
Telephone: 646-962-4000
Fax: 646-962-0110
Email: [email protected]
Abstract:
Acute cholecystitis in patients who are not suitable for surgery can benefit from EUS-
GBD to avoid percutaneous transhepatic gallbladder drainage (PT-GBD) associated
with poor quality of life and increased morbidity.
The technique involves EUS guided access of the gallbladder with creation of a gastric
or duodenal fistula followed by placement of a stent. The overall reported technical
success rate is 87/90 (96.6%). A total of 11/90 (12.2%) patients had complications
including pneumoperitoneum, bile peritonitis and stent migration.
EUS-GBD provide gallbladder drainage in situations where percutaneous or
transpapillary drainage is not feasible or technically challenging, it also offer the patients
a better option with improved quality of life and decreased global morbidity by avoiding
percutaneous access.
Introduction:
Surgical cholecystectomy has been the mainstay of treatment for acute cholecystitis.
For patients with advanced age, comorbidities, use of anti-platelet medications, and/or
the presence of advanced malignancy, gallbladder drainage has been recommended
instead of surgery.[1] Techniques for non-surgical gallbladder drainage include
percutaneous transhepatic gallbladder aspiration or drainage (PT-GBD) and
transpapillary endoscopic gallbladder stenting.[2] Endoscopic transpapillary drainage
can be technically difficult in some cases with biliary or pancreatic malignancy due to
cystic duct obstruction or previously placed metal stents. The need for alternative
methods of gallbladder drainage during the evolution of EUS guided drainage
techniques for extraluminal collections such as pseudocysts has lead to development of
EUS guided gallbladder drainage (EUS-GBD) techniques.[3-6]
.
Materials and methods:
Echoendoscopes
Conventional curved linear array oblique viewing therapeutic echoendoscopes are
typically used (GF-UCT 180, Olympus America, Melville, NY). The working channel of
this scope is 3.7 mm, allowing placement of 10 mm fully covered metal stents and 10 F
double pigtail stents.[7] Itoi and colleagues have also reported the use of a prototype
forward view curved linear array echoendoscope, which may enable the endoscopist to
overcome this issue by exerting force directly with the scope towards the target.[8]
Patient selection and preparation
Contrast enhanced abdominal CT or magnetic resonance imaging should be reviewed
as a roadmap prior to endoscopic intervention. This procedure is frequently performed
under general anesthesia, although conscious sedation is also used at the discretion of
the endoscopist. Peri-procedural antibiotics are often administered.
EUS guided gallbladder drainage technique (Table 1)
Endoluminal puncture site
Endoscopic ultrasound is used to identify the site of initial puncture at a location where
the gallbladder lies closest to the bowel lumen, avoids blood vessels and a stable
position of the endoscope tip can be easily maintained. The gastric antral wall has been
the preferred site for the initial puncture to access in few large case series,[9-11] while
some authors report the use of a transduodenal approach with similar success rates.[8,
12] Lee and colleagues reported use of the transgastric approach to access the body of
the gallbladder and the transduodenal approach for the gallbladder neck.[13] In early
reports of EUS-GBD, Lee et al. and Baron et al. commented that directing the puncture
needle to the gallbladder neck can be advantageous since it is less mobile and is less
likely to move away from the duodenal wall.[13, 14]
Puncture needle
Most reports have consistently used a 19 gauge fine needle aspiration (FNA) needle to
obtain access (Figure 1). Subtil et al. have described use of a one step device
(Giovannini Needle Wire Oasis, Cook Ireland Ltd, Limerick, Ireland), which allows
puncture, dilation, electrocautery, and placement of the stent in one device.[11] This
system is advantageous because it reduces the time that passes from the initial needle
puncture until stent deployment, which reduces the risk of loss of guidewire access and
potential complications. However, this system is only available for 8.5 and 10 F straight
stents.[11]
Tract dilator
After gaining access with a 0.035 inch guidewire, which is coiled into the gallbladder,
the fistula tract is dilated using either a mechanical or electrocautery device (Figure 2).
A biliary dilation catheter (Soehendra, Cook Medical) has been used as the initial
dilating device in many reports.[10, 13, 15-17] A triple lumen cystoenterostome (6F or
10F Cysto-Gastro Set, Endo-flex, Voerde, Germany or Cystotome, Cook Endoscopy) is
another preferred dilation device, which can assist in dilation using diathermy and/or a
needle knife.[15] [8-12, 16] A cystoenterostome has the advantage of performing
dilation without lifting the ultrasound probe from the gut wall while diathermy causes
melting of tissue and inflammatory reaction which can aid in keeping the tissue layers
together. [12] Some authors have described the use of 4 mm hurricane biliary balloon
dilator either alone or in tandem with the methods mentioned above to achieve
adequate dilation.[8, 9]
Endoprosthesis
After tract dilation, the stent delivery system or stent followed by the pushing catheter is
advanced over the wire and into the cyst. The tip of echoendoscope is then carefully
lifted from the luminal wall maintaining the direction to allow visualization of the stent
deployment. The distal end of stent is deployed under fluoroscopic guidance, then the
proximal end is then deployed endoscopically. The stent length is determined by the
combined thickness of the interposed tissue as measured by EUS (Figure 3).
Plastic biliary stents (PBS) were used in most early studies describing EUS-GBD. A
variety of PBS such as double pigtail, single pigtail and straight have been used with
similar success rates (Table 1). [11-13, 16-18] The insertion of a plastic stent usually
requires a tract diameter slightly larger than the stent to be placed, which could lead to a
gap and potential leakage. [10] Self expanding metal stents (SEMS) were used for
EUS-GBD in one case series of fifteen patients in an attempt to circumvent the
limitations of PBS by sealing the gap between the stent and the fistula as the stent
expands. [10] SEMS can also be repositioned if desired, avoiding the need for a second
puncture. Jang and colleagues described the use of 10 mm diameter covered metal
stents (BONA-AL Standard Sci Tech Inc, Seoul, Korea), which are modified with flared
ends up to 22 mm to prevent migration. [10] The larger diameter of the stent lumen also
decreases risk of stent occlusion. Lumen-apposing stents (AXIOS, Xlumena Inc,
Mountain View, California) are the newest development in the arena of EUS-GBD. The
AXIOS stents have a 10 mm diameter with bilateral anchor flanges, which provide
lumen to lumen apposition and prevent leakage. [8] It is also possible to access the
gallbladder lumen through the stent with a slim endoscope to perform biopsies, remove
stones or for debridement.[8, 9, 19]
Literature Review (Table 1)
Indications for the procedures included patients with acute cholecystitis that were not
suitable for surgical cholecystectomy due to malignancy or other comorbidities and/or
after failed endoscopic transpapillary gallbladder stenting. The initial needle puncture
was made in a transgastric fashion in 54/73 patients (74%) and transduodenally in
19/73 patients (26%). One study including 30 patients did not specify whether the
puncture was performed transgastrically or transduodenally. Nasocystic drainage tubes
were used in 41/103 (39.8%) patients, plastic stents were used in 16/103 (15.5%) of
patients, and covered metal stents were used in 46/103 (44.6%) patients.
The overall reported technical success rate is 100/103 (97.1%). Technical failures were
attributed to loss of guidewire access (n = 1), uncontrolled stent release (n = 1) and
cobblestone gallbladder limiting advancement of guidewire (n = 1). Clinical success
defined as improvement in clinical and laboratory parameters was achieved in 100%
patients when EUS-GBD was technically successful.
A total of 11/103 (10.7%) patients had complications. Pneumoperitoneum (n = 6) was
the most commonly reported complication and was self-limited in all cases. [10, 13, 15,
16] Bile peritonitis (n = 1) and stent migration (n = 1) were reported with placement of
PBS.[16] Bile peritonitis was managed conservatively. Distal stent migration was seen
as a late complication at 3 weeks post-procedure and was without clinical consequence.
[16] AXIOS stents have been associated with self-limited hematochezia (n = 1), right
hypochondrium pain (n = 1) and oozing at fistula site (n = 1). [8, 9] Other procedure
related events reported include: transient dislodgement of cystoenterostome requiring a
second puncture with a resultant small bile leak, and clogging, migration or
spontaneous expulsion of stent without clinical consequences. [9, 11, 12, 15, 16]
Discussion:
Percutaneous techniques have been used for gallbladder drainage for years with good
technical and clinical success rates. Risks involved with PT-GBD include liver injury
secondary to puncture causing hemorrhage, pneumothorax, bile leak, dislodged tube,
and skin site infections, which compromise quality of life and increase length of hospital
stay. [2] PT-GBD has a complication rate ranging up to 12%[20] and issues such as
catheter related pain, management of bile bag and cosmetic problems affect quality of
life. [21] Most patients treated with percutaneous techniques eventually will need a
cholecystectomy or acute cholecystitis can recur.[22] To overcome these limitations,
there has been a need for find alternative techniques to manage patients with acute
cholecystitis who are poor surgical candidates.
ET-GBD can be technically challenging in the setting of acute cholecystitis and has a
risk of post-ERCP pancreatitis.[23, 24] It may not be feasible in patients with an
inaccessible papilla or biliary obstruction due to malignancy. EUS-GBD can be a
valuable alternative in selected patients not candidates of PT-GBD or ET-GBD. EUS-
GBD is carried out through gastric or duodenal wall, avoiding puncture of liver, which is
more vascular and is safer in patients with coagulopathy or using anti-platelet agents.
[7-13, 15-18] It can also be performed safely in patients with perihepatic ascites where
PT-GBD is not feasible.
The technique of EUS guided drainage has evolved over past decade with drainage of
extraluminal collections such as pancreatic pseudocysts, necrosis and abscesses. [25,
26] We have previously reported drainage of bilomas and gallbladder fossa fluid
collections with success. [6, 27] Baron and colleagues first reported successful EUS
guided transduodenal gallbladder drainage using double pigtail PBS in a patient with
cholangiocarcinoma and bilateral metal biliary stents. [14] Limited apposition of PBS
with the tract wall lead to bile leak and stent migration[11, 16], although it has been
postulated that thickened gallbladder wall and or surrounding adhesions can decrease
the risk of bile leak. [13, 14] Most authors have used 7 F or 8.5 F diameter PBS which
could clog due to thick drainage. [16] SEMS avoid these potential limitations of PBS by
causing apposition at the tract wall to decrease chances of leakage and a have wider
internal diameter that reduces the risk of clogging. Jang and colleagues described use
of partially covered SEMS modified by adding flaring and angulations at the distal ends
to prevent stent migration.[10] The ends of SEMS have the potential to cause injury and
bleeding by abutting with the gallbladder or bowel lumen, although this has not been
reported.[28] The lumen apposing AXIOS stent is another modification of SEMS by
means of a “saddle” shape with distal anchor flanges to ensure both lumen apposition
and drainage. Three recent case series involving 31 patients have shown reasonable
success rates.[8, 9, 19] Deployment of AXIOS stents can be technically challenging,
particularly in patients with a thickened gallbladder wall leading to low technical success
rates in the initial pilot study. [9] These stents have been shown to provide an additional
advantage of allowing access to the gallbladder lumen with slim (<10 mm) endoscope to
perform biopsies, stone removal or debridement. [8, 9, 19]
Early experience with EUS-GBD procedures has shown minimal adverse events.
Pneumoperitoneum, the most common adverse event, was reported only in case series
using a biliary dilation catheter for tract dilation. Due to lack of detailed information on
individual cases, pneumoperitoneum cannot be clearly be attributed to biliary dilation
catheters, but it has been postulated that the sheer force by the dilators has potential to
detach and push away the gallbladder wall possibly leading to pneumoperitoneum.
SEMS or lumen-apposing AXIOS stents are promising since complications associated
with PBS such as bile leak and stent migration have not been reported. EUS-GBD with
placement of SEMS or AXIOS stent is a reasonable palliative option in patients with
malignancy affecting biliary system and avoids recurrence of cholecystitis due to stent
blockage or removal as seen with other techniques which use smaller diameter drains.
EUS-GBD with AXIOS can also aid in treatment of large stones by performing
cholecystoscopy. [9]
In summary, EUS-GBD is an evolving alternative to PT-GBD or ET-GBD in selected
patients as a bridge to surgery or for palliation. The potential to perform therapeutic
maneuvers will expand its applications in future. With continued development of EUS
drainage accessories and experience with the drainage techniques, EUS-GBD is likely
to have better technical success rates with minimal adverse events. With the
widespread adoption of EUS-GBD, the indications are likely to expand. It can potentially
be an access point for therapies directed towards biliary tree or liver such as
photodynamic therapy, radiofrequency ablation through a transcystic approach in
patients with inaccessible ampulla due to malignancy or altered anatomy after bariatric
surgery.
Table Legend
Table 1: Summary of studies describing endoscopic ultrasound guided
gallbladder drainage
Table 1: Summary of studies describing endoscopic ultrasound guided gallbladder drainage
Author/Year/lo
cation
Num
ber of
cases
Indications Initial
puncture
site
Tract
dilatior
Endoprost
hesis for
drainage
Mean
proced
ure
time
(min)
Techni
cal
success
rate
Clini
cal
succe
ss
rate
Length of
follow up
Limitatio
ns
Complicat
ions
Moon et al. [19]
2014
Korea
13 Acute
cholecystitis,
gallbladder
cancer,
pancreatic fluid
collections
Stomach 6-8F
dilating
catheter
Needle
knife
4 mm
balloon
catheter
Lumen
apposing
stent
(AXIOS,
Xlumena
Inc,
Mountain
View, CA)
10 mm
diameter
Not
reporte
d
100% 100% 6 months None None
Jang et al.[15]
2012
Korea
30 Acute
cholecystitis
unsuitable for
emergency
cholecystectom
y
Stomach
or
duodenal
wall
(numbers
not
specified)
6F
dilator
catheter
(43.3%)
Triple
lumen
needle
knife
(56.7%)
5 F
nasobiliary
drainage
tube
23 ± 7 97% 100% 221 days
(6 days for
patients who
underwent
cholecystect
omy)
Loss of
guide
wire
access
Pneumoperito
neum (2/30)
Self limiting
Itoi et al.[8]
2012
Japan
5 Aute
cholecystitis in
non-surgical
candidates
(3 pancreatic
cancers, 1
cholangiocarci
noma
1 gallstone
1 stomach
4
duodenum
4 mm
hurrican
e
dilating
balloon
(N=4)
10F
cystoto
Lumen
apposing
stent
(AXIOS,
Xlumena
Inc,
Mountain
View, CA)
10 mm
23.4 100% 100% 9 months None Mild self
limited oozing
along fistula
tract
disease) me
(N=1)
diameter
(length
6mm in 4
cases and
10 mm in
one case)
Serna-Higuera et
al.[9]
2012
Spain
13 Acute
cholecystitis in
non surgical
candidates for
emergent
cholecystectom
y
12/13
transgastri
c-antral
1/13
transduode
nal
8.5F
Cystoto
me
followed
by 4mm
hurrican
e biliary
balloon
dilator
-Lumen
apposing
stent
(AXIOS,
Xlumena
Inc,
Mountain
View, CA)
-Additional
fully
covered
SEMS
within
AXIOS in 4
subjects
Not
reporte
d
84.6% 100% 100.81 days Thickene
d
gallbladd
er wall
Uncontrol
led stent
release
Hematochezia
(1/11)
Right hypo-
chondrium
pain (1/11)
Both self
limiting
Jang et al. [10]
2011
Korea
15 Acute
Cholecystitis
unsuitable for
cholecystectom
y after failed
ERCP with
transpapillary
cystic approach
10/15
transgastri
c-
prepyloric
antrum
5/15
transduode
nal
-6 or 7 F
Soehend
ra
biliary
dilation
catheter
-Triple
lumen
needle
knife
microto
me
Partially
covered
SEMS 10
mm
diameter
and 4-7 mm
length
(Modified*
BONA-AL
Stent,
Standard
Sci Tech
Inc, Seoul,
Korea)
Not
reporte
d
100% 100% 145 days None Pneumoperito
neum (2/15)
Self limiting
Song et al. [16]
2010
Korea
8 Acute
Cholecystitis
poor surgical
candidates
after failed
7/8
transduode
nal
1/8
transgastri
-6 or 7 F
tapered
tip
biliary
dilation
7F double-
pigtail
plastic stent
28
(range
17-32)
100% 100% 186 days Clogging
of stent
(no
clinical
conseque
1 pneumo-
peritoneum
(self limiting)
1 bile
peritonitis
transpapillary
cystic approach
(4
cholangiocarci
noma, 2 liver
cirrhosis, 1 on
anticoagulation
, 1 malignant
cystic duct
obstruction)
c catheter
-7F
Triple
lumen
needle
knife
microto
me (6/8)
nce) 1 distal stent
migration
Subtil et al. [11]
2010
Spain
4 Acute
cholecystitis
with
perforation and
perigallbladder
abscess in non
surgical
candidates
(1
Alzheimer’s, 3
advanced
hepatobiliary
malignancies)
Transgastr
ic-
prepyloric
antrum
-10F
cystoto
me (1
case)
-One-
step
system
NWOA
(Giovan
nini
Needle
Wire
Oasis (3
cases)
8.5F stent
modified
Cotton-
Leung®
(Amsterda
m)
10F stent
modified
Soehendra
Tannenbau
m Biliary
Not
reporte
d
100% 100% Not reported Stent
migration
into gall
bladder
Spontane
ous stent
expulsion
None
Kamata et al.
[17]
2009
Japan
1 Acute
cholecystitis in
patient with
malignant
biliary
obstruction
treated with
covered SEMS
Transgastr
ic
Serial 6
Fr, 7 Fr,
and 9 Fr;
Soehend
ra
biliary
dilation
catheters
7F X 4 cm
double
pigtail
Not
reporte
d
100% 100% 6 months None None
Takasawa et
al.[18]
2009
Japan
1 Acute
cholecystitis in
patient with
malignant
biliary
obstruction
after SEMS
Transgastr
ic
Needle
knife
papiloto
me
7.2 Fr, 30
cm-long,
single
pigtail
plastic tube
Not
reporte
d
100% 100% 10 days None None
Kwan et al. [12]
2007
Belgium
3 Acute
Cholecystitis in
non surgical
candidates
1
Transgastr
ic-antral
2
transduode
nal
6F or
10F
Cysto-
Gastro
Set
[Endo-
flex,
Voerde,
German
y]
Cystoto
me
[Cook
endosco
py]
Single
pigtail
nasocholec
ystic drain
together or
followed by
8.5F
Double-
pigtail stent
(Zimmon
biliary
stent)
Not
reporte
d
100% 100% 6 weeks Transient
dislodge
ment of
cysto-
enterosto
me
causing
small bile
leak and
requiring
repeat
puncture
None
Lee et al.[13]
2007
Korea
9 Acute
Cholecystitis
(Gallstone
induced) in
elderly or high
risk due to co
morbidities or
on
anticoagulation
not suitable
emergent
cholecystectom
y
4
transgastri
c
5
transduode
nal
6F or 7F
bougie
(Soehen
dra
biliary
dilatatio
n
catheter)
5F
nasobiliary
drainage
tube
20
(range
10-35)
100% 100% 3-12 months None Pneumoperito
neum (1/9)
self limiting
Baron et al.[14]
2007
USA
1 Acute
Cholecystitis in
patient with
cholangiocarci
noma with
bilateral metal
biliary stents
Transduod
enal
4 mm
balloon
7F X 4cm
double
pigtail
biliary stent
Not
reporte
d
100% 100% 11 weeks None None
Abbreviations: SEMS- Self-Expandable Metal Stents; Modified BONA-AL - modified by enlarging the flares (22-mm external
diameter) and the ends of the stent had 90°angulation to prevent migration after placement,
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FIGURE LEGENDS
1-Figure 1: EUS guided puncture of the gallbladder
2-Figure 2: Fluoroscopy images of balloon dilation
3-Figure 3: Endoscopic images of deployed lumen apposing metal stent between the gallbladder and the bulb
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