Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.
Prophylactic Endoscopic Ultrasound Gallbladder Drainage (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.
Ocurrence of acute cholecystitis
Technical success rate: EUS-GBD
EUS-guided gallbladder drainage
Study Arms / Comparison Groups
EUS-guided gallbladder drainage
Description: In one arm, Endoscopic Ultrasound-Gallbladder Drainage (EUS-GBD) will be performed by using a 3,8 mm therapeutic echoendoscope and a lumen apposing metal stent ( Hot AXIOS™ Stent and Electrocautery Enhanced Delivered System; Boston Scientific Corporation, Natick, MA, USA) after conventional biliary drainage with self-expandable metallic stents during endoscopic retrograde cholangiopancreatography (ERCP). All procedures will be performed under general anesthesia.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
July 1, 2018
July 27, 2020
Primary Completion Date
December 27, 2019
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.
18 Years - N/A
Accepts Healthy Volunteers
Carlos Robles-Medranda, ,
Instituto Ecuatoriano de Enfermedades Digestivas
Carlos Robles-Medranda, Principal Investigator, Instituto Ecuatoriano de Enfermedades Digestivas