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Time Interval for Endoscopic Variceal Ligation

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ClinicalTrials.gov Identifier: NCT01291277
Recruitment Status : Completed
First Posted : February 8, 2011
Results First Posted : December 26, 2016
Last Update Posted : February 13, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Variceal Bleeding Device: Endoscopic Variceal Ligation Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Appropriate Time Interval for Repeat Sessions of Endoscopic Ligation for the Eradication of Esophageal Varices
Study Start Date : August 2008
Primary Completion Date : September 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: variceal banding

Outcome Measures

Primary Outcome Measures :
  1. Proportion of Patients With Eradication of Esophageal Varices [ Time Frame: At 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291277

United States, California
L.A. County + U.S.C. Medical Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Yale University
VA Connecticut Healthcare System
Principal Investigator: Loren Laine, M.D. University of Southern California
More Information

Responsible Party: Loren Laine, Investigator, University of Southern California
ClinicalTrials.gov Identifier: NCT01291277     History of Changes
Other Study ID Numbers: HS-08-00172
First Posted: February 8, 2011    Key Record Dates
Results First Posted: December 26, 2016
Last Update Posted: February 13, 2017
Last Verified: December 2016

Keywords provided by Loren Laine, University of Southern California:
gastrointestinal hemorrhage
esophageal varices
gastrointestinal endoscopy

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases