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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Mansoura univeristy
RECRUITING
Al Mansurah
Contact Information
Primary
Mennatallah E Saad, Asslecturer
mennaehab@mans.edu.eg
0502200590
Backup
Ahmed Y Altonbary, Assprofessor
a.tonbary@gmail.com
0502200590
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 72
Treatments
Active_comparator: Combined EUS-HGS and ERCP 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
Active_comparator: ERCP biliary drainage
bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage
Related Therapeutic Areas
Sponsors
Leads: Mansoura University

This content was sourced from clinicaltrials.gov