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

Recruiting now · Not applicable

Conditions studied: Malignant Hilar Stricture

In brief

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

Key facts

Study ID

NCT06613945

Run by

Mansoura University

People needed

72

Starts

2024-09-01

Expected to finish

2026-10-30

Last updated by the study team

2024-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Mansoura univeristy — Al Mansurah, Dakahlia Governorate, Egypt (enrolling)

Full record on ClinicalTrials.gov

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