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Time Interval for Endoscopic Variceal Ligation

University of Southern California logo

University of Southern California

Status and phase

Completed
Phase 4

Conditions

Variceal Bleeding

Treatments

Device: Endoscopic Variceal Ligation

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01291277
HS-08-00172

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Ligation: 1-week interval
Active Comparator group
Description:
Endoscopic variceal ligation performed at 1-week intervals
Treatment:
Device: Endoscopic Variceal Ligation
Ligation 2-week interval
Active Comparator group
Description:
Endoscopic variceal ligation performed at 2-week intervals
Treatment:
Device: Endoscopic Variceal Ligation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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