Phase 4
N=90
Time Interval for Endoscopic Variceal Ligation
Variceal Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT01291277 ↗Enrolled (actual)
90
Serious AEs
34.4%
Results posted
Dec 2016
Primary outcome: Primary: Proportion of Patients With Eradication of Esophageal Varices — 37; 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Endoscopic Variceal Ligation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Eradication of Esophageal Varices |
37; 23 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01291277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.