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

Not Applicable

Recruiting

• Conditions: Malignant Hilar Stricture
• Interventions: Procedure: Combined ERCP and EUS-HGS biliary drainage; Procedure: ERCP biliary drainage

• Registration Number: NCT06613945
• Lead Sponsor: Mansoura University

Brief 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

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-01
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26
• Primary Completion: 2025-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type III & IV only.
• Histologically confirmed malignant hilar biliary obstruction.
• Elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
• Absence of duodenal narrowing/obstruction.
• Accept sharing in the study

Exclusion Criteria

• Pregnancy.
• Distal biliary obstruction as the main lesion.
• Benign biliary stenosis.
• Malignant hilar biliary obstruction bismuth type I and II.
• Presence of duodenal obstruction.
• Surgically altered anatomy or inability to access the major duodenal papilla.
• Patients underwent previous intervention for biliary drainage.
• Previously failed biliary cannulation at ERCP.
• Large volume ascites.
• Patients unfit for anesthesia.
• Patients having uncorrectable coagulopathy or thrombocytopenia.
• History of allergy to radiocontrast agents.
• Refuse sharing in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Technical success	during the procedure	considered after stent placement (expanded and patent) with good bile flow and drainage
Procedural duration	at the end of the procedure	defined as time from biliary cannulation to stent placement by ERCP, and time from needle puncture of the dilated bile duct to stent placement by EUS
Clinical success	3 month	considered at 2 weeks by a 50% decrease in total bilirubin levels from baseline and at 4 weeks if total bilirubin is less than 3mg/dL.
Re-interventions	3 month	need for re-intervention to secure biliary drainage

Secondary Outcome Measures

Name	Time	Method
Adverse events	3 month	Early adverse events (within 48 hours after procedure) including: pancreatitis, cholangitis, bleeding, perforation and peritonitis.; - Late adverse events include stent dysfunction either due to food impaction, tumor ingrowth or stent migration

Trial Locations

Locations (1)

Mansoura univeristy; 🇪🇬 Mansoura, Dakahlia, Egypt