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: mkahaleh@gmail.com

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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2. Itoi, T., N. Coelho-Prabhu, and T.H. Baron, Endoscopic gallbladder drainage for management of acute cholecystitis. Gastrointest Endosc, 2010. 71(6): p. 1038-45.

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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