Time Interval for Endoscopic Variceal Ligation

Phase 4

Completed

• Conditions: Variceal Bleeding
• Interventions: Device: Endoscopic Variceal Ligation

• Registration Number: NCT01291277
• Lead Sponsor: University of Southern California

Brief Summary

Patients with liver disease frequently present to the hospital with bleeding from dilated veins in their foodpipe (called esophageal varices). The current standard of care is to perform endoscopic variceal ligation (placing rubber bands around the varices through an endoscope)in patients presenting with bleeding varices. Patients generally receive ligation at the time they come in with bleeding and then return at regular intervals to have repeat ligation in order to eradicate the varices. However there have been no studies to determine the appropriate intervals for esophageal variceal ligation until eradication. We will conduct a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in patients that have presented with bleeding varices. Our hypothesis is that one-week ligation will achieve more rapid eradication than the two-week interval with a greater proportion of patients achieving variceal eradication at 4 weeks after the index bleeding episode.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2011-02-04
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-08
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Results First Submitted: 2016-10-25
• Results First Submitted QC: 2016-10-31
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-23
• Results First Posted: 2016-12-26
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients who presented with acute upper GI bleeding due to esophageal varices and underwent successful endoscopic variceal ligation.
• Patients who would normally receive repeat endoscopic ligation therapy to eradicate varices.

Exclusion Criteria

• Persistent bleeding despite endoscopic and medical therapy
• Platelet count < 40,000

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ligation 2-week interval	Endoscopic Variceal Ligation	Endoscopic variceal ligation performed at 2-week intervals
Ligation: 1-week interval	Endoscopic Variceal Ligation	Endoscopic variceal ligation performed at 1-week intervals

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Eradication of Esophageal Varices	At 4 weeks

Trial Locations

Locations (1)

L.A. County + U.S.C. Medical Center; 🇺🇸 Los Angeles, California, United States