Evaluating combined EUS and ERCP for treating bile duct obstructions
Endoscopic Retrograde Cholangiopancreatography With and Without Endoscopic Ultrasound Guided Hepaticogastrostomy for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
This study is testing whether a new method that combines two procedures can help people with advanced bile duct blockages feel better compared to just one of the procedures alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT06613945 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of combining Endoscopic Ultrasound Guided Hepaticogastrostomy (EUS-HGS) with Endoscopic Retrograde Cholangiopancreatography (ERCP) for bilateral biliary decompression in patients with advanced malignant hilar biliary obstruction. Participants will be randomly assigned to receive either ERCP alone or the combined approach, with outcomes measured including technical success, clinical success, procedural duration, and rates of adverse events. Follow-up assessments will occur at one and three months post-procedure to evaluate the effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates are patients with inoperable malignant hilar biliary obstruction and elevated liver tests.
Not a fit: Patients with benign biliary stenosis or those with previous failed biliary interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve biliary drainage and reduce complications for patients with malignant hilar biliary obstruction.
How similar studies have performed: While the combination of EUS-HGS and ERCP is a novel approach, similar studies have shown promising results in improving biliary drainage outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Mansoura univeristy — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Mennatallah E saad, asslecturer — Mansoura University
- Study coordinator: Mennatallah E Saad, Asslecturer
- Email: mennaehab@mans.edu.eg
- Phone: 0502200590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.