Time Interval for Endoscopic Variceal Ligation

NCT01291277 | Completed Phase 4 Results

• 1 other identifier: HS-08-00172
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Variceal Bleeding

Keywords

gastrointestinal hemorrhage; esophageal varices; gastrointestinal endoscopy; ligation

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Eradication of Esophageal Varices

  At 4 weeks

Study Arms (2)

Ligation: 1-week interval

ACTIVE COMPARATOR

Endoscopic variceal ligation performed at 1-week intervals

Device: Endoscopic Variceal Ligation

Ligation 2-week interval

ACTIVE COMPARATOR

Endoscopic variceal ligation performed at 2-week intervals

Device: Endoscopic Variceal Ligation

Interventions

Endoscopic Variceal Ligation DEVICE

Ligation of esophageal varices

Also known as: variceal banding

Ligation 2-week interval; Ligation: 1-week interval

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Persistent bleeding despite endoscopic and medical therapy
• Platelet count \< 40,000

Sponsors & Collaborators

• University of Southern California: lead
• Yale University: collaborator
• VA Connecticut Healthcare System: collaborator

Study Sites (1)

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

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Hypertension, Portal; Liver Diseases

Results Point of Contact

• Title: Dr. Loren Laine
• Organization: Yale School of Medicine

loren.laine@yale.edu

203-937-3462

Study Officials

• Loren Laine, M.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 8, 2011
• Study Start: August 1, 2008
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 13, 2017
• Results First Posted: December 26, 2016

Record last verified: 2016-12

Locations

US (1)