Phase 4
Completed N=90
Time Interval for Endoscopic Variceal Ligation
Variceal Bleeding
Source: ClinicalTrials.gov NCT01291277 ↗
Enrolled (actual)
90
Serious AEs
34.4%
Results posted
Dec 2016
Primary outcomePrimary: Proportion of Patients With Eradication of Esophageal Varices — 37; 23 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Eradication of Esophageal Varices |
37; 23 | — |
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. Informational only — not medical advice.