A comparison of two methods for facilitating endoscopic treatment of obstructive jaundice.

Phase 3

Completed

• Conditions: Obstructive jaundice requiring biliary drainage

• Registration Number: CTRI/2012/12/003248
• Lead Sponsor: Vinay Dhir MDDNB

Brief Summary

This is an open label randomized controlled trial in patients with obstructive jaundice requiring biliary drainage. 208 patients who fail selective biliary cannulation with a guidwire/sphincterotome will be randomized to receive either a precut papillotomy or EUS guided rendezvous procedure. Primary outcome will be successful biliary drainage in one session. Secondary outcome measures will be total procedure time, complications, duration of hospital stay and mortality.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-07
• Last Update Posted: 2013-09-24
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

Patients with obstructive jaundice and accessible papilla requiring biliary drainage.

Exclusion Criteria

bleeding diathesis duodenal obstruction previous precut papillotomy poor general condition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
successful biliary drainage in one session measured at the completion of the procedure	successful biliary drainage in one session

Secondary Outcome Measures

Name	Time	Method
total procedure time	complications

Trial Locations

Locations (1)

Institute of advanced endoscopy; 🇮🇳 Mumbai, MAHARASHTRA, India

Institute of advanced endoscopy

🇮🇳Mumbai, MAHARASHTRA, India

Dr Vinay Dhir

Principal investigator

22-23685577

vinaydhir@gmail.com