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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
Sponsor:
Collaborators:
Yale University
VA Connecticut Healthcare System
Information provided by (Responsible Party):
Loren Laine, University of Southern California

Study Description
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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
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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
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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

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

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
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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


Locations
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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
Investigators
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Principal Investigator: Loren Laine, M.D. University of Southern California
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Loren Laine, Investigator, University of Southern California
ClinicalTrials.gov Identifier: NCT01291277    
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
ligation