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OpenTrials
Completed

NCT Number: NCT01291277

Time Interval for Endoscopic Variceal Ligation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

L.A. County + U.S.C. Medical Center

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic variceal ligation

Device

Ligation of esophageal varices

Other names: variceal banding

Primary outcomes

  1. Proportion of Patients With Eradication of Esophageal Varices

    Time frame: At 4 weeks

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • VA Connecticut Healthcare System
  • Yale University

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Feb 8, 2011
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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