Study Overview

Details

NCTId: NCT03729882

Status: Completed

Condition: Acute Cholecystitis

Study Type: Interventional

Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas

Study Description

Brief

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).

Detailed

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.

Eligibility

Criteria:

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.

Healthy Volunteers: No

Gender: All

Min Age: 18 Years

Contacts

Instituto Ecuatoriano de Enfermedades Digestivas

Guayaquil

Guayas

090505

Ecuador

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