Time Interval for Endoscopic Variceal Ligation

Variceal Bleeding Clinical Trial

Official title:

Appropriate Time Interval for Repeat Sessions of Endoscopic Ligation for the Eradication of Esophageal Varices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291277
• Other study ID #: HS-08-00172
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2011
• Last updated: December 5, 2015
• Start date: August 2008
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Variceal Bleeding

Intervention

Device:
• Endoscopic Variceal Ligation
Ligation of esophageal varices

Locations

Country	Name	City	State
United States	L.A. County + U.S.C. Medical Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	VA Connecticut Healthcare System, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with eradication of esophageal varices		At 4 weeks	No