Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.
Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.
to determine if primary prophylaxis with Endoscopic Ultrasound-Gallbladder Drainage (EUS-GBD)
 in unresectable cancer patients with the orifice of the cystic duct (OCD) involvement is
 superior to conservative management (Non EUS-guided gallbladder drainage).
Endoscopic biliary drainage with a self-expandable metal stent (SEMS) is an accepted form of
 palliative therapy for distal malignant biliary obstruction (MBO); it is a low invasive
 procedure with a long-term patency.

 Covered SEMSs have a longer patency than uncovered SEMSs in patients with MBO, because
 covered SEMSs can prevent tumor ingrowth. However, complications of covered SEMSs include
 stent occlusion, migration, kinking, non-occlusion cholangitis, liver abscess, pancreatitis
 and cholecystitis.

 Nonsurgical decompression of the gallbladder is urgently needs to prevent sepsis, perforation
 and death in patients with acute cholecystitis. Several risk factors of cholecystitis after
 SEMS placement for distal MBO have been reported: however, tumor involvement to the orifice
 of the cystic duct (OCD) is the major predictive factor for cholecystitis after endoscopic
 SEMSs placement for distal MBO palliative treatment .

 Acute cholecystitis related to SEMSs deployment was evaluated in 2009, by using endoscopic
 trans-papillary gallbladder drainage (TPGBD) in 11 individuals in whom SEMSs covered the OCD.
 None episode of cholecystitis was reported, however TPGBD is a difficult technique with a
 high rate of stent dislodgement and reintervention needed.

 EUS-GBD by using a lumen apposing metal stent have been proposed, but only for acute
 cholecystitis treatment or symptomatic gallbladder hydrops, never as a prophylactic
 technique.

 The aim of this study if to determine if primary prophylaxis EUS-GBD in patients with distal
 malignant biliary obstruction and the OCD involvement is superior than conservative
 management. Also, a cost-effectiveness analysis will be done in both arm groups.

 This would be the first trial to study the effect of prophylactic EUS-GBD prior SEMSs
 deployment in patients with distal malignant biliary obstruction.
Inclusion Criteria:

 -  Above 18 years old.

 -  Obtained written consent for procedures

 -  Unresectable malignant biliary obstruction diagnosed by Endoscopic Ultrasound and
 confirmed by confocal laser endomicroscopy (CLE) during cholangioscopy and
 histopathology.

 -  Tumor involvement to the orifice of the cystic duct.

 -  Self-expandable metallic plastic stent deployment as palliative therapy for distal
 biliary obstruction.

 Exclusion Criteria:

 -  Under 18 years old.

 -  Refuse to sign written informed consent.

 -  Pregnancy

 -  Previous cholecystectomy

 -  Acute cholecystitis prior enrollment

 -  Severe ascites that increases the distance between gastric or duodenal and gallbladder
 walls.

 -  Large vessel between the gallbladder and gastric-duodenal wall.

 -  Coagulopathy

 -  Intrahepatic cholangiocarcinoma

 -  Previous gallbladder drainage by percutaneous or endoscopic techniques.