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Time Interval for Endoscopic Variceal Ligation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Southern California.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Yale University
VA Connecticut Healthcare System
Information provided by (Responsible Party):
Loren Laine, University of Southern California
ClinicalTrials.gov Identifier:
NCT01291277
First received: February 4, 2011
Last updated: January 13, 2013
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Variceal Bleeding
Device: Endoscopic Variceal Ligation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Appropriate Time Interval for Repeat Sessions of Endoscopic Ligation for the Eradication of Esophageal Varices

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Proportion of patients with eradication of esophageal varices [ Time Frame: At 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2008
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ligation: 1-week interval
Endoscopic variceal ligation performed at 1-week intervals
Device: Endoscopic Variceal Ligation
Ligation of esophageal varices
Other Name: variceal banding
Active Comparator: Ligation 2-week interval
Endoscopic variceal ligation performed at 2-week intervals
Device: Endoscopic Variceal Ligation
Ligation of esophageal varices
Other Name: variceal banding

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291277

Contacts
Contact: Loren Laine, M.D. 323-409-7995 llaine@usc.edu

Locations
United States, California
L.A. County + U.S.C. Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Loren Laine, M.D.    323-409-7995    llaine@usc.edu   
Principal Investigator: Loren Laine, M.D.         
Sponsors and Collaborators
University of Southern California
Yale University
VA Connecticut Healthcare System
Investigators
Principal Investigator: Loren Laine, M.D. University of Southern California
  More Information

No publications provided

Responsible Party: Loren Laine, Investigator, University of Southern California
ClinicalTrials.gov Identifier: NCT01291277     History of Changes
Other Study ID Numbers: HS-08-00172
Study First Received: February 4, 2011
Last Updated: January 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
gastrointestinal hemorrhage
esophageal varices
gastrointestinal endoscopy
ligation

ClinicalTrials.gov processed this record on October 23, 2014