CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Endoscopic Variceal Ligationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01291277
NCT01291277Phase 4Completed

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

University of Southern California·interventional·Posted Feb 8, 2011·Updated Feb 13, 2017

In Brief

A Phase 4 clinical trial evaluating Endoscopic Variceal Ligation for Variceal Bleeding. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2011
Enrollment StartAug 1, 2008
Primary CompletionSep 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 15.4 years ago

Interventions

Endoscopic Variceal Ligationdevice

Ligation of esophageal varices