NCT06613945

ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction

Endoscopic Retrograde Cholangiopancreatography With and Without Endoscopic Ultrasound Guided Hepaticogastrostomy for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective randomized clinical trial to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced malignant hilar biliary obstruction. The primary outcome will be technical success, clinical success, procedural duration, and re-interventions. Secondary outcomes will be the rate of adverse events. patients will be followed up at 1 and 3 month intervals

Detailed description

Bilateral stenting by Endoscopic Retrograde Cholangiopancreatography in malignant hilar biliary obstructions (MHBO) is challenging and technically difficult. EUS hepaticogastrostomy (EUS-HGS) has been increasingly used as an alternative method to achieve internal biliary drainage in MHBO. Because of the difficulty of ERCP in such scenario, the combination of EUS-HGS and ERCP provides a possible chance of longer stent patency with less event of stent clogging Aim of the work: to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced MHBO. The inclusion criteria will be presence of inoperable MHBO with elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal The study patients will be randomized in 1:1 ratio to: ERCP biliary drainage (ERCP-BD) group: bilateral metallic stents insertion will be attempted by transpapilary approach. Combined ERCP and EUS-HGS group: unilateral metallic stent will be inserted on right side by transpapilary approach and a transmural stent will be inserted on left side by EUS. technical success, clinical success, procedural duration, and re-interventions and adverse events will be assesed

Conditions

• Malignant Hilar Stricture

Interventions

Type	Name	Description
PROCEDURE	ERCP biliary drainage	bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage
PROCEDURE	Combined ERCP and EUS-HGS biliary drainage	unilateral metallic stent will be inserted on right side by ERCP and a hepaticogastrostomy transmural stent will be inserted on left side by EUS to secure biliary drainage.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-10-30
• Completion: 2026-10-30
• First posted: 2024-09-26
• Last updated: 2024-09-26

Locations

1 site across 1 country: Egypt