450 Copyright © 2018 Korean Society of Gastrointestinal Endoscopy

REVIEWClin Endosc 2018;51:450-462https://doi.org/10.5946/ce.2018.024Print ISSN 2234-2400 • On-line ISSN 2234-2443

Endoscopic Ultrasound-Guided Gallbladder Drainage Using a Lumen-Apposing Metal Stent for Acute Cholecystitis: A Systematic Review

Deepanshu Jain1, Bharat Singh Bhandari2, Nikhil Agrawal3 and Shashideep Singhal4

1Division of Gastroenterology and Hepatology, Department of Digestive Diseases and Transplantation, Internal Medicine, Einstein Healthcare Network, Philadelphia, PA, 2Department of Internal Medicine, Saint Vincent Hospital, Worcester, MA, 3Department of Internal Medicine, University of Buffalo, Buffalo, NY, 4Division of Gastroenterology, Hepatology and Nutrition, University of Texas Health Science Center at Houston, Houston, TX, USA

Surgery remains the standard treatment for acute cholecystitis except in high-risk candidates where percutaneous transhepatic gallblad-der drainage (PT-GBD), endoscopic transpapillary cystic duct stenting (ET-CDS), and endoscopic ultrasound-guided gallbladder drain-age (EUS-GBD) are potential choices. PT-GBD is contraindicated in patients with coagulopathy or ascites and is not preferred by pa-tients owing to aesthetic reasons. ET-CDS is successful only if the cystic duct can be visualized and cannulated. For 189 patients who underwent EUS-GBD via insertion of a lumen-apposing metal stent (LAMS), the composite technical success rate was 95.2%, which in-creased to 96.8% when LAMS was combined with co-axial self-expandable metal stent (SEMS). The composite clinical success rate was 96.7%. We observed a small risk of recurrent cholecystitis (5.1%), gastrointestinal bleeding (2.6%) and stent migration (1.1%). Cautery enhanced LAMS significantly decreases the stent deployment time compared to non-cautery enhanced LAMS. Prophylactic placement of a pigtail stent or SEMS through the LAMS avoids re-interventions, particularly in patients, where it is intended to remain in situ in-definitely. Limited evidence suggests that the efficacy of EUS-GBD via LAMS is comparable to that of PT-GBD with the former show-ing better results in postoperative pain, length of hospitalization, and need for antibiotics. EUS-GBD via LAMS is a safe and efficacious option when performed by experts. Clin Endosc 2018;51:450-462

Key Words: Acute cholecystitis; Endoscopic ultrasound; Lumen-apposing metal stent

Open Access

IntRoDUCtIon

Approximately 20 million Americans are estimated to have gallstones, and approximately 300,000 cholecystectomies are performed annually.1 Approximately 1%–2% of patients with asymptomatic gallstones become symptomatic each year. Acute

cholecystitis, which is the most common complication of gall-stones occurs in 10% of symptomatic patients.2

Surgery—open or laparoscopic (performed preferentially) is the standard treatment for acute cholecystitis.3 Cholecystecto-my rates were observed to increase rapidly initially, after which they stabilized in the late 1990s and currently may even be declining in the U.S.4 Surgery is contraindicated in a few pa-tients with advanced age and multiple comorbidities. Non-sur-gical gallbladder drainage (GBD) can be performed via a per-cutaneous transhepatic (PT) or an endoscopic route with or without an endoscopic ultrasound (EUS).

Perihepatic ascites and coagulopathy are relative contrain-dications for PT-GBD. PT-GBD causes postoperative pain in approximately 12% of patients.5 Additionally, catheter obstruc-tion, dislodgement and migration require multiple post-pro-cedural interventions and long-term care. PT-GBD can be use-

Received: January 7, 2018 Revised: February 14, 2018 Accepted: February 18, 2018Correspondence: Shashideep SinghalDivision of Gastroenterology, Hepatology and Nutrition, University of Texas Health Science Center at Houston, 6431 Fannin, MSB 4.234, Houston, TX 77030, USAtel: +1-713-500-6677, Fax: +1-713-500-6699, E-mail: sdsinghal@gmail.comoRCID: https://orcid.org/0000-0002-8783-4889

cc This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

451

Jain D et al. EUS-Guided GBD via LAMS

ful as either a bridge to surgery or occasionally is planned as destination therapy, although patients may report discomfort from external drainage tubes and reject this procedure owing to aesthetic reasons.

In the absence of EUS, endoscopic drainage of the GB has been attempted via a transpapillary approach aimed at stent-ing the cystic duct. This technique is feasible only if the cystic duct shows opacification on a cholangiogram and a guide-wire can be successfully passed into the cystic duct. Reportedly, the technical success rate (TSR) of this approach is approximately 91%.6 Common complications include bleeding, stent migra-tion or occlusion, sedation-related adverse events, and those associated with the endoscopic retrograde cholangiopancrea-tography (ERCP) procedure itself.

EUS-GBD is a relatively newer application of the EUS-guid-ed approach to create an iatrogenic fistula between the GB and the gastrointestinal (GI) tract. EUS-GBD has been performed using plastic stents, nasobiliary drainage tubes, or self-ex-pandable metal stents (SEMS); however, the high risk of stent migration and bile leakage secondary to lack of apposition of the luminal walls has been considered an obstacle to achieving safe clinical outcomes. A lumen-apposing metal stent (LAMS) is a saddle-shaped stent designed from braided nitinol wires with double-walled flanges perpendicular to the lumen on both sides to provide adequate anchorage across the non-ad-herent luminal structures. It is completely covered with silicone to counteract tissue ingrowth and tract leakage and to allow removability. In this article, we summarize the indications, technique, outcomes, and adverse events associated with EUS-GBD using LAMS based on our review of 10 original studies.

MAtERIALS AnD MEtHoDS

Two authors individually reviewed the English literature from inception through September 2017. PubMed and Google Scholar were used to identify peer-reviewed original and re-view articles using the following key words: “Lumen-apposing metal stents (LAMS)”, “gallbladder drainage”, and “endoscopic ultrasound”. Only studies involving humans were selected. The references cited for pertinent studies were manually searched to identify additional relevant studies. Our search results yield-ed 10 studies.7-16 Indications, procedural details, technical and clinical outcomes, as well as adverse events with their manage-ment were reviewed for each study.

RESULtS

Ten original studies were included in our review article.

All were retrospective studies7-15 except 1.16 Three studies en-rolled patients from multiple centers11,15,16 and the rest were single-center studies.7-10,12-14 The reported literature described studies from the US,8,10-13,15 Spain,7 Japan,9 Germany14 and the Netherlands.16 Details regarding all studies have been summa-rized in Table 1.

Patient characteristicsMost patients in our study cohort were aged ≥60 years7-16

with only a few patients aged <50 years.11,13,15 Our study showed an even distribution of women (47.1%) and men (52.9%) in a ratio of 1:1.1.7-16 The retrospective studies that compared outcomes between EUS-GBD and PT-GBD showed no statis-tically significant intergroup differences in terms of baseline population characteristics, etiology of cholecystitis, site of ob-struction, median thickness of the GB wall, median duration of cholecystitis, and antibiotic exposure prior to the planned intervention.15

IndicationsThe most common indication for the procedure was acute

cholecystitis7,9,11-16 in addition to acute cholangitis,8 GB hy-drops,10,11 or biliary obstruction.11 The underlying etiology was either an isolated condition or a combination of cholelithiasis, choledocholithiasis, acalculous cholecystitis, or malignancies such as pancreatic adenocarcinoma, cholangiocarcinoma, or GB adenocarcinoma.7-16 All such patients had been deemed poor surgical candidates and had either refused to undergo PT-GBD or preferred to undergo EUS-GBD.7-12,14-16 A study showed that all patients who underwent PT-GBD continued to remain poor surgical candidates during follow-up and re-quired management with internal drainage using EUS-GBD.13 In patients with biliary obstruction, ERCP failed to relieve ob-struction secondary to technically challenging anatomy.8 In addition to patient preference, PT-GBD was considered unsafe in a few patients with concomitant perihepatic ascites, or co-agulopathy, and in those who needed to continue the use of blood thinners, or were at a high risk of tube dislodgement (patients with dementia, and agitated behavior, among other such conditions).11

Procedural characteristics

AnesthesiaOnly 4 studies described the nature of anesthesia used for

the procedure, which varied from general,11,15 and monitored anesthesia14,16 to conscious sedation.16 These results are highly center specific. No patient-reported outcomes are available to compare procedure tolerance across different studies, al-though the TSR remained comparable independent of the

452

Tabl

e 1.

Des

cripti

ve S

umma

ry of

Each

Indiv

idual

Stud

y

Stud

y Lo

catio

nty

pe o

fst

udy

num

ber o

fPa

tient

sIn

dica

tion/

Dis

ease

Age

(yr)

an

d se

xte

chni

cal

outc

ome

Clin

ical

ou

tcom

eFo

llow

up

dura

tion

Sten

t left

/re-

trie

ved

Adv

erse

even

ts

de la

Ser

na-H

igue

ra

et a

l. (2

013)

7

Spa

in

Retro

spec

tive

Cas

e ser

ies

13In

dica

tion-

1. A

cute

c

hole

cysti

tis

(no

n-su

rgic

al

can

dida

te)

Etio

logy

- 1

. Cho

lelith

iasis

- 9

/13

2

. Cho

lelith

iasis

+ P

ancr

eatic

canc

er-

2/1

3 3

. Cho

lelith

iasis

+ C

hola

ngio

carc

inom

a- 1

/13

4. Ch

olan

gioc

arcin

oma-

1/1

3

1. M

ean

age-

7

9.9

(ra

nge,

57–9

7)2.

Gen

der

dist

ribut

ion-

a) F

- 5 b

) M- 8

1. S

ucce

ss-

11/

13

(84

.6%

) 2.

Fai

lure

of

ins

ertio

n- 2

/13

a) 1

/2- T

ight

c

obbl

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ne G

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) 1/2

- U

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tent

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dep

loym

ent

int

o th

e gas

tric

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umen

-

Succ

ess-

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11

(10

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Para

met

er-

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mm

edia

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sym

ptom

relie

f2.

Nor

mal

izat

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FTs a

nd

acu

te p

hase

r

eact

ants

1. M

ean-

100

.81

days

(ra

nge,

24–

210

)

1. S

tent

left

in

situ

- 10/

112.

Ste

nt re

trie

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(no

rep

lace

men

t s

tent

pla

ced

due

to sy

mpt

om

res

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and

col

lapse

of G

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Com

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emat

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out a

nem

ia- 1

/2

(re

solv

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ith

con

serv

ativ

e Mx)

2. M

ild ri

ght u

pper

q

uadr

ant p

ain-

1/2

(

reso

lved

with

c

onse

rvat

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x)

Itoi e

t al.

(20

13)8

USA

Cas

e Rep

ort

1In

dica

tion-

1

. Acu

te ch

olan

gitis

(

ERCP

tech

nica

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c

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duo

dena

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72.

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der

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) M- 1

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ess-

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ram

eter

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. Clin

ical

s

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nor

mal

ized

1 yr

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tent

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tu-

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e

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dica

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cute

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on-s

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cal

can

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te)

1. A

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62.

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der

dist

ribut

ion-

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- 1 b

) M- 0

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cces

s- 1

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N/A

1. S

tent

retr

ieve

d-

1/1

(2 w

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t p

lace

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t alo

ng

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20 ×

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m

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e r

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e

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016)

10

USA

Cas

e rep

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ende

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) M- 1

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al

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ptom

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o1.

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nt in

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/1N

one

453

Jain D et al. EUS-Guided GBD via LAMS

Tabl

e 1.

Con

tinue

d

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catio

nty

pe o

fst

udy

num

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fPa

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tion/

Dis

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(yr)

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d se

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outc

ome

Clin

ical

ou

tcom

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llow

up

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Sten

t left

/re-

trie

ved

Adv

erse

even

ts

Iran

i e

t al.

(201

5)11

USA

Mul

ticen

ter

Ret

rosp

ectiv

e15

Indi

catio

n-

1. A

cute

calc

ulou

s c

hole

cysti

tis- 7

/15

2. N

on ca

lcul

ous

cho

lecy

stitis

- 4/1

5 3

. Bili

ary

obstr

uctio

n- 2

/15

4. G

allb

ladd

er

hyd

rops

- 1/1

5 5

. Sym

ptom

atic

c

holel

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sis- 1

/15

(A

ll w

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on-

sur

gica

l can

dida

tes

and

all r

efus

ed

per

cuta

neou

s d

rain

age)

1. M

edia

n a

ge- 7

4 (

rang

e, 42

–89)

2. G

ende

r d

istrib

utio

n-

a) F

- 7 b

) M- 8

1. S

ucce

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14/

15 (9

3%)

2. S

ucce

ss w

ith a

ssist

ance

- 1/1

5 (

salv

aged

by

pla

cing

SEM

S v

ia L

AM

S)

Succ

ess-

1

5/15

(100

%)

Mea

n- 1

60 (

rang

e, 3

9– 2

60)

day

sM

odal

ity-

Pho

ne ca

lls,

Clin

ic v

isits,

I

mag

ing

stu

dies

1. S

tent

in si

tu-

15/

15

Com

posit

e pro

cedu

re

rela

ted

AE-

11.

Pos

t-pro

cedu

re fe

ver-

1

/15

(suc

cess

fully

trea

ted

with

antib

iotic

s)

Kum

ta

et a

l. (2

016)

12

USA

Cas

e rep

ort

1In

dica

tion-

chro

nic

calc

ulou

s c

hole

cysti

tis

(no

t a su

rgic

al

can

dida

te an

d re

fuse

d p

ercu

tane

ous

dra

inag

e)

1. A

ge- 7

7 ye

ars

2. G

ende

r d

istrib

utio

n- a

) F- 1

Succ

ess-

1/1

(

100%

)Su

cces

s-

1/1

(100

%)

Para

met

er-

1. C

linic

al

sym

ptom

s

6 m

o1.

Ste

nt le

ft in

situ

- 1

/1N

one

Law

e

t al.

(201

6)13

USA

Retro

spec

tive

Sing

le ce

nter

Cas

e ser

ies

7In

dica

tion-

acut

e c

alcul

ous c

holec

ystit

is (

prio

r per

cuta

neou

s d

rain

and

poor

s

urgi

cal c

andi

date

s)

1. M

edia

n A

ge- 5

7 (

rang

e, 32

– 81

)2.

Gen

der

dist

ribut

ion-

a) F

-1 b

) M -

6

Succ

ess-

5

/7 (7

1.4%

)Su

cces

s with

a

ssist

ance

- 2/7

(

salv

aged

with

S

EMS

pla

cem

ent

thr

ough

LA

MS)

Succ

ess-

7

/7 (1

00 %

)Pa

ram

eter

- 1

. Clin

ical

s

ympt

oms

4 m

o (

Inte

rqua

rtile

ran

ge, 3

.5–

5.5

)

1. S

tent

left

in si

tu-

4/7

2.

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nt re

trie

ved-

3/7

a

) 2/3

- rep

lace

d w

ith d

oubl

e p

igta

il ste

nt at

6

wee

ks an

d 4

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b) 1

/3- r

emov

ed

to

allo

w st

one

ext

ract

ion

whi

ch

spo

ntan

eous

ly

pas

sed

into

i

leos

tom

y ba

g

Non

e

454

Tabl

e 1.

Con

tinue

d

Stud

y Lo

catio

nty

pe o

fst

udy

num

ber o

fPa

tient

sIn

dica

tion/

Dis

ease

Age

(yr)

an

d se

xte

chni

cal

outc

ome

Clin

ical

ou

tcom

eFo

llow

up

dura

tion

Sten

t left

/re-

trie

ved

Adv

erse

even

ts

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lhop

f e

t al.

(201

7)14

Ger

man

y

Retro

spec

tive

Sing

le ce

nter

75In

dica

tion

- acu

te

calc

ulou

s a

nd ac

alcu

lous

c

hole

cysti

tis

(po

or su

rgic

al

can

dida

tes)

1. M

edia

n a

ge- 7

5±11

(

rang

e, 41

–96)

2.

Gen

der

dist

ribut

ion-

a) F

- 39

b) M

- 36

1. S

ucce

ss-

74/

75 (9

8.7%

)2.

Fai

lure

- 1/7

5 (

equi

pmen

t m

alfun

ctio

ning

- l

eadi

ng to

g

astr

ic

per

fora

tion

man

aged

s

urgi

cally

)

Succ

ess-

7

1/74

(95.

9%)

Para

met

er-

1. C

linic

al

sym

ptom

s Fa

ilure

- 3/7

4 (

deat

h on

pos

t p

roce

dure

d

ay 3

, 13

and

27

seco

ndar

y t

o w

orse

ning

s

epsis

)

1. M

ean:

2

01±2

26 (

rang

e, 2

–1,1

92)

day

s

1. S

tent

left

in si

tu-

69/

752.

Ste

nt re

trie

ved-

5

/75

3. S

tent

m

igra

tion-

1/7

5 (

spon

tane

ous,

per

siste

nt

cho

lecy

sto-

gas

tric

fistu

la

with

no

clini

cal

con

sequ

ence

s)

Com

posit

e pro

cedu

re r

elate

d A

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01.

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or b

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0 (

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lved

with

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a) 1

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tail

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lace

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a LA

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igra

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) 1/2

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ratio

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to G

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t 8 m

pos

t pro

cedu

re

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dosc

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oval

and

rep

lace

men

t with

a

noth

er L

AM

S) b

) 1/2

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igra

tion

at d

ay 5

pos

t p

roce

dure

(end

osco

pic

ste

nt re

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nd

clo

sure

of fi

stula

with

c

lip)

4. B

ouve

ret s

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ome-

1

/10-

4 m

pos

t pro

cedu

re

(en

dosc

opy

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otrip

sy o

f occ

ludi

ng

sto

ne5.

Sep

sis-

3/1

0- le

adin

g to

dea

th

455

Jain D et al. EUS-Guided GBD via LAMS

Tabl

e 1.

Con

tinue

d

Stud

y Lo

catio

nty

pe o

fst

udy

num

ber o

fPa

tient

sIn

dica

tion/

Dis

ease

Age

(yr)

an

d se

xte

chni

cal

outc

ome

Clin

ical

ou

tcom

eFo

llow

up

dura

tion

Sten

t left

/re-

trie

ved

Adv

erse

even

ts

Dol

lhop

f e

t al.

(201

7)14

Ger

man

y

Retro

spec

tive

Sing

le ce

nter

75In

dica

tion

- acu

te

calc

ulou

s a

nd ac

alcu

lous

c

hole

cysti

tis

(po

or su

rgic

al

can

dida

tes)

1. M

edia

n a

ge- 7

5±11

(

rang

e, 41

–96)

2.

Gen

der

dist

ribut

ion-

a) F

- 39

b) M

- 36

1. S

ucce

ss-

74/

75 (9

8.7%

)2.

Fai

lure

- 1/7

5 (

equi

pmen

t m

alfun

ctio

ning

- l

eadi

ng to

g

astr

ic

per

fora

tion

man

aged

s

urgi

cally

)

Succ

ess-

7

1/74

(95.

9%)

Para

met

er-

1. C

linic

al

sym

ptom

s Fa

ilure

- 3/7

4 (

deat

h on

pos

t p

roce

dure

d

ay 3

, 13

and

27

seco

ndar

y t

o w

orse

ning

s

epsis

)

1. M

ean:

2

01±2

26 (

rang

e, 2

–1,1

92)

day

s

1. S

tent

left

in si

tu-

69/

752.

Ste

nt re

trie

ved-

5

/75

3. S

tent

m

igra

tion-

1/7

5 (

spon

tane

ous,

per

siste

nt

cho

lecy

sto-

gas

tric

fistu

la

with

no

clini

cal

con

sequ

ence

s)

Com

posit

e pro

cedu

re r

elate

d A

E- 1

01.

Maj

or b

leed

ing-

1/1

0 (

reso

lved

with

c

onse

rvat

ive

man

agem

ent)

2. R

ecur

rent

chol

ecys

titis-

3

/10

a) 1

/3- c

onse

rvat

ive

man

agem

ent

b) 2

/3- d

oubl

e pig

tail

ste

nt p

lace

d vi

a LA

MS

3. M

igra

tion-

2/1

0 a

) 1/2

- pro

xim

al

mig

ratio

n in

to G

B a

t 8 m

pos

t pro

cedu

re

(en

dosc

opic

rem

oval

and

rep

lace

men

t with

a

noth

er L

AM

S) b

) 1/2

- int

raga

stric

m

igra

tion

at d

ay 5

pos

t p

roce

dure

(end

osco

pic

ste

nt re

trie

val a

nd

clo

sure

of fi

stula

with

c

lip)

4. B

ouve

ret s

yndr

ome-

1

/10-

4 m

pos

t pro

cedu

re

(en

dosc

opy

and

lith

otrip

sy o

f occ

ludi

ng

sto

ne5.

Sep

sis-

3/1

0- le

adin

g to

dea

th

Tabl

e 1.

Con

tinue

d

Stud

y Lo

catio

nty

pe o

fst

udy

num

ber o

fPa

tient

sIn

dica

tion/

Dis

ease

Age

(yr)

an

d se

xte

chni

cal

outc

ome

Clin

ical

ou

tcom

eFo

llow

up

dura

tion

Sten

t left

/re-

trie

ved

Adv

erse

even

ts

Iran

i e

t al.

(201

7)15

USA

, Eur

ope,

Asia

Retro

spec

tive

Mul

ticen

ter

EUS

guid

ed

GB

dra

inag

e (

EUS-

GBD

)- 4

5

Indi

catio

n -

1) A

cute

calc

ulou

s a

nd ac

alcu

lous

c

hole

cysti

tis (p

oor

sur

gica

l can

dida

tes)

1. M

edia

n a

ge- 5

5 (

rang

e, 25

–87)

2. G

ende

r d

istrib

utio

n- a

) F- 1

6 b

) M- 2

9

1. S

ucce

ss-

44/

45 (9

8%)

2. S

ucce

ss w

ith

ass

istan

ce- 1

/45

(sa

lvag

ed w

ith

10 ×

60 m

m

ful

ly co

vere

d b

iliar

y m

etal

s

tent

pla

ced

via

LA

MS)

1. S

ucce

ss-

43/

45 (9

6%)

2. M

edia

n pa

in

sco

re o

n po

st p

roce

dure

Day

1

- 2.5

(

rang

e, 1–

9)3.

Med

ian

hos

pita

l sta

y p

ost

int

erve

ntio

n- 3

(ra

nge,

1–23

)4.

Num

ber o

f r

e-in

terve

ntio

ns-

11

215

(ran

ge,

1–6

21) d

ays

1. S

tent

left

in si

tu-

44/

44C

ompo

site p

roce

dure

r

elate

d A

E- 8

1. B

leed

ing-

2/8

a) 1

/2- 3

day

s pos

t p

roce

dure

(tre

ated

by

clo

t eva

cuat

ion

and

pig

tail

stent

pla

cem

ent

thr

ough

LA

MS)

b)

1/2

- 6 m

o po

st p

roce

dure

(sto

pped

s

pont

aneo

usly

with

r

ever

sal o

f coa

gulo

path

y)

2. R

ecur

rent

chol

ecys

titis-

3

/8 (6

, 8 an

d 12

mo

post

pro

cedu

re)

a) 1

/3- t

reat

ed w

ith

ant

ibio

tics

b) 2

/3- e

ndos

copi

c p

lace

men

t of p

igta

il ste

nt

via

LA

MS

3. B

ile le

ak w

ith

per

itoni

tis- 1

/8- D

ay 3

p

ost p

roce

dure

(req

uire

d p

ercu

tane

ous d

rain

) 4.

Abd

omin

al p

ain-

1/8

- d

ue to

food

occ

ludi

ng

tra

ns-g

astr

ic L

AM

S (

evac

uatio

n of

food

, b

allo

on d

ilatio

n of

g

ranu

latio

n ov

ergr

owth

a

nd p

igta

il ste

nt

pla

cem

ent v

ia L

AM

S)5.

Sep

sis- 1

/8- p

erfo

rate

d G

B le

adin

g to

dea

th

456

Tabl

e 1.

Con

tinue

dSt

udy

Loca

tion

type

of

stud

yn

umbe

r of

Patie

nts

Indi

catio

n/D

isea

seA

ge (y

r)

and

sex

tech

nica

l ou

tcom

eC

linic

al

outc

ome

Follo

w u

p du

ratio

nSt

ent l

eft/r

e-tr

ieve

dA

dver

se ev

ents

Iran

i e

t al.

(201

7)15

USA

, Eur

ope,

Asia

Perc

utan

eous

tra

nshe

patic

d

rain

age

of G

B (

PT-G

BD)-

45

1. M

edia

n a

ge- 7

5 (

34–9

4)

2.G

ende

r d

istrib

utio

n- a

) F- 1

8 b

) M- 2

7

Succ

ess-

4

5/45

(100

%)

(p=

0.98

)

1. S

ucce

ss- 4

1/45

(91

%) (

p=0.

12)

2. M

edia

n pa

in

sco

re o

n po

st p

roce

dure

Day

1

- 6.5

(ran

ge,

2–1

0) (p

=0.0

01)

3. M

edia

n h

ospi

tal s

tay

pos

t i

nter

vent

ion-

9 (r

ange

, 1–1

21)

(p=

0.01

)4.

Num

ber o

f r

e-in

terv

entio

ns-

112

(p=0

.001

)

265

(ran

ge,

1–1

,638

) d

ays

Not

appl

icab

leC

ompo

site p

roce

dure

rela

ted

AE-

14

1. R

ecur

rent

chol

ecys

titis-

4

/14

(Trt

with

Abx

and

dra

in ex

chan

ge)

a) 1

/4- d

rain

d

islod

gem

ent o

n po

st p

roce

dure

day

8 b

) 3/4

- dra

in o

cclu

sion

on

post

proc

edur

e 2, 4

a

nd 6

mo

2. A

bdom

inal

pai

n w

ithou

t cho

lecy

stitis

- 3

/14

(dra

in o

cclu

sion

Trt

with

exch

ange

)3.

Cell

uliti

s- 1

/14

(Trt

with

o

ral A

bx)

4. B

ile le

ak- 3

/14

a) 1

/3- l

ead

to se

psis

and

dea

th b

) 2/3

- add

ition

al d

rain

pla

cem

ent

5. S

epsis

- 2/1

4 (le

ad to

d

eath

)6.

Jeju

nal fi

stula

- 1/1

4 (

allo

wed

trac

k to

mat

ure

fol

low

ed b

y EU

S-G

BD)

Wal

ter

et a

l. (2

016)

16

Net

herla

nds

Pros

pect

ive

Mul

ticen

ter

30In

dica

tion-

Acu

te

calc

ulou

s a

nd ac

alcu

lous

c

hole

cysti

tis (

poor

surg

ical

c

andi

date

s)

1. M

edia

n a

ge- 8

5 (

rang

e, 68

–97)

2. G

ende

r d

istrib

utio

n a

) F- 1

9 b

) M- 1

1

27/3

0 (9

0%)

26/2

7 (9

6%)

1. 2

98±8

2 da

ys fo

r al

l pat

ient

s 2.

364

±82

days

for

patie

nts

aliv

e at t

he

end

of st

udy

1. S

tent

left

in si

tu-

15/

302.

Ste

nt re

trie

ved-

1

5/30

Com

posit

e pro

cedu

re r

elate

d A

E- 6

1. R

ecur

rent

c

hole

cysti

tis- 2

/6 (d

ue to

L

AM

S ob

struc

tion

req

uirin

g its

rem

oval

)2.

Asp

iratio

n pn

eum

onia

- 1

/6 (l

eadi

ng to

dea

th)

3. P

ancr

eatic

infe

ctio

n-

1/6

(lea

ding

to d

eath

)4.

Mele

na/ t

hrom

bus i

n G

B- 1

/6 (r

esol

ved

with

c

onse

rvati

ve m

anag

emen

t) 5.

Jaun

dice

(hem

obili

a)-

1/6

(res

olve

d w

ith

con

serv

ative

man

agem

ent)

GB,

gall

blad

der;

LFT,

live

r fun

ctio

n te

sts; A

E, ad

vers

e eve

nts;

Mx,

man

agem

ent;

ERCP

, end

osco

pic r

etro

grad

e cho

langi

opan

crea

togr

aphy

; N/A

, not

avai

lable;

SEM

S, se

lf-ex

pand

able

met

al st

ent;

LAM

S, lu

men

-app

osin

g m

etal

sten

t; EU

S-G

BD, e

ndos

copi

c ultr

asou

nd-g

uide

d ga

llblad

der d

rain

age;

PT-G

BD, p

ercu

tane

ous t

rans

hepa

tic ga

llblad

der d

rain

age;

Trt,

treat

men

t; Ab

x, an

tibio

tics.

457

Jain D et al. EUS-Guided GBD via LAMS

type of anesthesia used.

Stent specificsThe LAMS is designed to allow apposition of the luminal

walls of 2 non-adherent organs. The endoscopist determines the size and length of the LAMS to be used after considering the patient-specific anatomy, GB wall thickness, and diameter of in situ GB stones (to allow unobstructed passage of the stent). Details regarding stents used by different studies have been summarized in Table 2. Because of increasing experience with the use of LAMS, a few authors recommend prophylac-tic placement of a SEMS or a plastic pigtail stent through the LAMS to prevent future occlusion and displacement.7,11,13,15 This practice is more useful in patients in whom the LAMS is intended to remain in situ indefinitely, to avoid the need for re-intervention. In addition to the above-mentioned studies, 2 authors used SEMS to provide additional length when the proximal flange of the LAMS was noted to deploy into the ex-traluminal space11,13,15 potentially salvaging a technical failure.

In our review, approximately 50% of the operations (48.2%) were performed using cautery enhanced LAMS12,14,15 and the rest were performed using non-cautery enhanced LAMS (51.8%).7-11,13,15,16

Site of punctureMost studies did not explain their choice of a transgastric vs.

a transduodenal or transjejunal approach. This decision is left to the discretion of the endoscopist after assessing the patient’s anatomy to determine the site of maximal direct apposition between the GB wall and the GI tract to allow LAMS place-ment. LAMS placement in porcine models is known to cause mature fistula tract formation within 4–5 weeks.17 The LAMS tends to cause significant tissue overgrowth, which serves as a drawback during stent removal. Walter et al. proposed that the retroperitoneal location of the duodenum allows stable tract formation compared to the stomach where peristaltic movements lead to a higher degree of tissue reaction conse-quently leading to tissue overgrowth.16

In our review comprising 189 patients, 75 (39.7%) underwent transgastric,7-9,11,14-16 113 (59.8%) underwent transduodenal,7,10-16 and 1 (0.5%) patient underwent transjejunal puncture14 to ac-cess the GB.

TechniqueAll authors used an oblique/forward viewing therapeutic lin-

ear array echoendoscope to visualize the GB. A standard 19-gauge needle was used to puncture the gastric antrum or the duodenal bulb to access the GB wall, and entry into the GB was confirmed using real-time ultrasound and color Doppler imag-ing. Next, the contrast agent was injected to obtain fluoroscopic

images of the biliary tree. A standard biliary guide-wire was coiled into the GB lumen. The tract was then dilated over the guide-wire using a balloon dilator or cystotome. A preloaded stent was then advanced over the guide-wire. The distal flange of the stent was first deployed into the GB and abutted against the wall under ultrasonographic or fluoroscopic guidance. Next, the proximal flange of the stent was deployed into the duode-num or the stomach under direct visualization, thereby perform-ing cholecystoenterostomy or cholecystogastrostomy, respec-tively. The stent position was confirmed endoscopically or fluoroscopically and via aspiration of biliary contents. If a cau-tery enhanced LAMS is being used, the puncture site, dilation of the tract and stent deployment can all be performed simulta-neously, thereby potentially decreasing the procedure time.

Procedure timeOnly 4 studies reported procedure times,11,14-16 which varied

widely between a minimum of 8 min14 and a maximum of 110 min.16 The mean procedure time varied from 22–38 min.11,14,15 The mean EUS-GBD procedure time was 6 min longer than that of a PT-GBD (p=0.02).15 Dollhopf et al. reported a signifi-cantly (p=0.04) shorter stent deployment time with the use of cautery enhanced LAMS (3.1 min) vs. non-cautery enhanced LAMS (7.7 min).14

technical outcomeThe TSR was determined by calculating the percentage of

patients who underwent successful LAMS deployment across the GB wall with drainage into the stomach or the small bow-el. The composite TSR (without SEMS) for EUS-GBD was 95.2% (180/189).7-16 The LAMS could not initially be deployed in 3 patients; however, a SEMS was successfully placed through the LAMS to bridge the gap across the GB wall to overcome this difficulty.11,13,15 The composite TSR (with SEMS) for EUS-GBD was 96.8% (183/189).7-16 The individual TSR (without SEMS) varied between 71.4%13 and 100%.8-10,12 The individual TSR (with SEMS) varied between 84.6%7 and 100%.8-13,15 Rea-sons for failure (n=6) could be attributed to a stiff cobblestone GB (1/6),7 uncontrolled stent release (1/6),7 equipment mal-function leading to gastric perforation (1/6),14 and unknown etiology (3/6).16 A study performed by Irani et al. showed that the TSR was comparable between EUS-GBD and PT-GBD (p=0.98).15

Clinical outcomesThe clinical success rate (CSR) was measured by calculating

the percentage of patients who showed significant improve-ment in clinical, laboratory, or radiological parameters post EUS-GBD via LAMS (with or without SEMS). The composite CSR was 96.7% (177/183).7-16 The individual CSR varied be-

458

Tabl

e 2.

Tech

nical

Detai

ls of

Proc

edur

e acro

ss E

ach S

tudy

Stud

y Lo

catio

n ty

pe o

f st

udy

num

ber o

fPa

tient

sSi

te o

f app

roac

h (g

astr

ic o

r duo

denu

m)

nee

dle s

ize

Sten

t spe

cific

sA

cces

sory

equi

pmen

tA

nest

hesia

Proc

edur

e du

ratio

n

de la

Ser

na-H

igue

ra

et a

l. (2

013)

7

Spa

in

Retro

spec

tive

Cas

e ser

ies

131.

Tra

nsga

stric

- 12/

13

2. T

rans

duod

enal

- 1/1

3 19

GA

. LA

MS-

1.

10×

10 m

m- 7

/11

2. 1

5×10

mm

- 4/1

13.

Fla

nge d

iam

eter

- 2

0 m

m (1

1/11

) B.

Coa

xial

SEM

S w

ithin

L

AM

S- 4

/11

1. L

inea

r ech

oend

osco

pe2.

0.0

35 in

ch g

uide

wire

3. 8

.5 F

Cys

toto

me

4. 4

mm

bili

ary

ballo

on

dila

tor

5. 1

0 m

m b

allo

on d

ilato

r

N/A

N/A

Itoi

et a

l. (2

013)

8

USA

Cas

e Rep

ort

1Tr

ansg

astr

ic- 1

/119

GA

. LA

MS

1. 1

0×10

mm

- 1/1

2.

Fla

nge d

iam

eter

- 2

0 m

m (1

/1)

1. L

inea

r ech

oend

osco

pe2.

4 m

m b

allo

on d

ilato

rN

/AN

/A

Itoi

et a

l. (2

014)

9

Jap

an

Cas

e rep

ort

1Tr

ansg

astr

ic- 1

/1N

/AA

. LA

MS

1. D

iam

eter

- 15

mm

N

/AN

/AN

/A

Thar

ian

et a

l. (2

016)

10

USA

Cas

e rep

ort

1Tr

ansd

uode

nal-

1/1

19 G

N/A

1. L

inea

r ech

oend

osco

pe2.

0.0

25 in

ch g

uide

wire

3. 4

mm

bal

loon

dila

tor

N/A

N/A

Iran

i e

t al.

(201

5)11

USA

Mul

ticen

ter

Retro

spec

tive

15Tr

ansd

uode

nal-

14/1

5Tr

ansg

astr

ic- 1

/15

19 G

A. L

AM

S1.

10×

10 m

m- 1

2/15

2.

15×

10 m

m- 3

/15

3. F

lang

e Dia

met

er-

a) 2

1 m

m- 1

2/15

b) 2

4 m

m- 3

/15

B. S

tent

thro

ugh

LAM

S 1.

7 F

× 4

cm d

oubl

e pig

t

ail s

tent

- 6/1

5 (

prop

hyla

ctic

) 2.

10×

6 cm

fully

cove

red

bili

ary

met

al st

ent-

1/15

1. L

inea

r ech

oend

osco

pe2.

0.0

25 in

ch

visi

glid

ewire

or 0

.035

i

nch

jagw

ire3.

4 m

m b

allo

on d

ilato

r o

r 6 F

/7 F

tape

red

dila

tor

4. O

ver t

he w

ire n

eedl

e k

nife

or 1

0 F

cysto

tom

e

Gen

eral

a

nesth

esia

1. M

edia

n- 3

8 (

rang

e, 15

–52)

m

in

Kum

ta

et a

l. (2

016)

12

USA

Cas

e rep

ort

1Tr

ansd

uode

nal-

1/1

N/A

A. L

AM

S w

ith ca

uter

y1.

15×

10 m

m

1. L

inea

r ech

oend

osco

pe2.

Gui

dew

ire3.

Bal

loon

dila

tor

N/A

N/A

459

Jain D et al. EUS-Guided GBD via LAMS

Tabl

e 2.

Con

tinue

d

Stud

y Lo

catio

n ty

pe o

f st

udy

num

ber o

fPa

tient

sSi

te o

f app

roac

h (g

astr

ic o

r duo

denu

m)

nee

dle s

ize

Sten

t spe

cific

sA

cces

sory

equi

pmen

tA

nest

hesia

Proc

edur

e du

ratio

n

Law

e

t al.

(201

6)13

USA

Retro

spec

tive

Sing

le ce

nter

Cas

e ser

ies

7Tr

ansd

uode

nal-

719

GA

. LA

MS

(dia

met

er/

len

gth)

1. 1

0 ×10

mm

- 5/7

2.

15 ×

10 m

m- 2

/7

B. S

tent

thro

ugh

LA

MS-

5/7

1. D

oubl

e pig

tail

stent

(

7 F

× 4

cm)-

3/7

2. B

iliar

y SE

MS

(10×6

cm) +

dou

ble p

ig

tai

l ste

nt (7

F ×

4 cm

)- 1

/7

3. B

iliar

y SE

MS

(10

mm

× 6

cm) +

bilia

ry

SEM

S (1

0 m

m ×

4 cm

)- 1

/7

1. L

inea

r ech

oend

osco

pe2.

450

cm- b

iliar

y g

uide

wire

3. C

ysto

stom

e (10

Fr)

or

bal

loon

dila

tor

N/A

N/A

Dol

lhop

f e

t al.

(201

7)14

Ger

man

y

Retro

spec

tive

Sing

le ce

nter

75Tr

ansd

uode

nal-

38

Tran

sgas

tric

- 36

Tran

sjeju

nal-

1

1. 1

9 G

- 32/

75

(42

.7%

)2.

No

need

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tween 95.9%14 and 100%.7-13 Among the 6 patients who showed a lack of response, GB wall perforation was considered the possible etiology in 2,14,15 and no obvious reason could be detected in the remaining 4 patients other than coexistent co-morbidities.14-16 The CSR of EUS-GBD (96%) was higher than that of PT-GBD (91%), although this result was not statistical-ly significant (p=0.12).15 Notably, the authors demonstrated a statistically significant decrease in the postoperative pain on day 1 (p=0.001), a shorter median length of hospitalization post-intervention (p=0.01), as well as fewer re-interventions (p=0.001) with EUS-GBD than with PT-GBD.15

Adverse events

SepsisLack of resolution of acute cholecystitis despite stent place-

ment resulted in progression to sepsis, necrosis of the GB wall, perforation, and death.14,15,16 These complications have been presented in detail under Clinical Outcomes.

Recurrent cholecystitisAmong the 177 patients who showed initial clinical resolu-

tion of symptoms, 9 (5.1%) presented with a repeat attack of acute cholecystitis. This condition usually occurs secondary to either stent dislodgement (usually in the early post-procedural period before the fistula matures into a tract), or occlusion (an early or late post-procedural complication) secondary to gall-stones, food bolus, clots, or tissue overgrowth over time. Pa-tients may improve with conservative management (antibiot-ics) alone14,15 or may require endoscopic debridement with placement of a pigtail stent through the LAMS or complete re-moval of the LAMS. A few authors recommend prophylactic placement of pigtail stents through the LAMS at the time of initial procedure to prevent this complication.7,11,13,15 A few au-thors also recommend performing endoscopic lavage with/without stone extraction via the LAMS after placement to prevent future attacks.7

BleedingIntraprocedural bleeding is an expected outcome because

the procedure involves the creation of a transmural fistula be-tween the GI tract and the GB wall. Bleeding was easily con-trolled in most patients and was not reported as a complication. Among 189 patients, 5 (2.6%) reported post-procedural GI bleeding,7-16 which in 4/5 patients were managed with conser-vative treatment alone (reversal of coagulopathy, administra-tion of intravenous fluids, and other such interventions).7,14-16 In 1 patient, endoscopic evaluation revealed a clot without ac-tive bleeding, which was treated with clot evacuation and placement of a pigtail stent through the LAMS.15 One patient Ta

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461

Jain D et al. EUS-Guided GBD via LAMS

developed hemobilia, which improved with supportive care alone.16

Stent migrationStent migration is a relatively rare complication with LAMS

placement compared to the placement of SEMS or pigtail cath-eters.

Among the 183 patients who underwent EUS-GBD via LAMS, only 2 (1.1%) showed stent migration.7-16 One event occurred on post-procedure day 5 (managed with stent re-trieval and clip closure of the fistula) and the other occurred 8 months post procedure (managed with LAMS replacement).14

MiscellaneousThese complications noted in the composite study cohort

(n=189) included abdominal pain in 1.1% of patients (1 pa-tient developed stent occlusion from a food bolus requiring endoscopic debridement and pigtail stent placement, and the other improved with supportive care alone),7,15 fever in 0.5% (improved with supportive care),11 bile leak with peritonitis in 0.5% (managed with percutaneous drain placement),15 Bou-veret syndrome in 0.5% (treated with endoscopic lithotripsy and stone removal),14 aspiration pneumonia in 0.5% (eventually leading to death)16 and pancreatic infection in 0.5% (eventually leading to death).16

ConCLUSIonS

The absence of an external drainage tube and widespread applicability in patients with coagulopathy or ascites make EUS-GBD using LAMS an attractive option for patients with acute cholecystitis in whom surgery is contraindicated. The procedure demonstrates a high TSR and CSR, although this evidence is based on the few high-volume centers where only a small number of experts perform this procedure. A learning curve has been suggested; however, the minimum training re-quirements are yet to be determined. Complications although rare, are associated with the risk of worsening the clinical situ-ation in already sick patients who are poor surgical candidates. Based on the available evidence, EUS-GBD using LAMS is a safe and efficacious alternative when performed by experts in high-risk surgical patients with acute cholecystitis.

Conflicts of InterestThe authors have no financial conflicts of interest.

Author ContributionsConceptualization: Deepanshu Jain

Data curation: DJ, Bharat Singh Bhandari, Nikhil AgrawalFormal analysis: DJInvestigation: DJ, Shashideep SinghalMethodology: DJProject administration: DJ, SSResources: DJSupervision: DJ, SSValidation: DJ, SS Visualization: DJWriting-original draft: DJ, BSB, NAWriting-review&editing: DJ, SS

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