Time Interval for Endoscopic Variceal Ligation

December 23, 2016 updated by: Loren Laine, University of Southern California

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • L.A. County + U.S.C. Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ligation: 1-week interval
Endoscopic variceal ligation performed at 1-week intervals
Device: Endoscopic Variceal Ligation
Ligation of esophageal varices
Other Names:
  • variceal banding
ACTIVE_COMPARATOR: Ligation 2-week interval
Endoscopic variceal ligation performed at 2-week intervals
Device: Endoscopic Variceal Ligation
Ligation of esophageal varices
Other Names:
  • variceal banding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Patients With Eradication of Esophageal Varices
Time Frame: At 4 weeks
At 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

Yale University
VA Connecticut Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

February 4, 2011

First Submitted That Met QC Criteria

February 4, 2011

First Posted (ESTIMATE)

February 8, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2017

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HS-08-00172

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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