Time Interval for Endoscopic Variceal Ligation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Variceal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ligation: 1-week interval

Endoscopic variceal ligation performed at 1-week intervals

Group Type ACTIVE_COMPARATOR

Endoscopic Variceal Ligation

Intervention Type DEVICE

Ligation of esophageal varices

Ligation 2-week interval

Endoscopic variceal ligation performed at 2-week intervals

Group Type ACTIVE_COMPARATOR

Endoscopic Variceal Ligation

Intervention Type DEVICE

Ligation of esophageal varices

Interventions

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Endoscopic Variceal Ligation

Ligation of esophageal varices

Intervention Type DEVICE

Other Intervention Names

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variceal banding

Eligibility Criteria

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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.