Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.

Instituto Ecuatoriano de Enfermedades Digestivas

Status: Completed

Conditions: Acute Cholecystitis

Treatments: Procedure: Non EUS-guided gallbladder drainage; Procedure: EUS-guided gallbladder drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT03729882

EUS-GBD

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

EUS-guided gallbladder drainage

Other group

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.

Treatment:

Procedure: Non EUS-guided gallbladder drainage

Procedure: EUS-guided gallbladder drainage

Non EUS-guided gallbladder drainage

Other group

Description:

In the other arm, patients will undergo conventional biliary drainage with self-expandable metallic stent placement during ERCP evaluation without prophylactic EUS-GBD and will be considered as a Non EUS-guided gallbladder drainage. All procedures will be performed under general anesthesia.

Treatment:

Procedure: Non EUS-guided gallbladder drainage