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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01291277
Other study ID # HS-08-00172
Secondary ID
Status Completed
Phase Phase 4
First received February 4, 2011
Last updated December 5, 2015
Start date August 2008
Est. completion date December 2015

Study information

Verified date December 2015
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Endoscopic Variceal Ligation
Ligation of esophageal varices

Locations

Country Name City State
United States L.A. County + U.S.C. Medical Center Los Angeles California

Sponsors (3)

Lead Sponsor Collaborator
University of Southern California VA Connecticut Healthcare System, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with eradication of esophageal varices At 4 weeks No
See also
  Status Clinical Trial Phase
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Recruiting NCT05629845 - Prevention of Variceal Rebleeding by EUS-guided vs Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients N/A
Completed NCT00570973 - Band Ligation Versus Transjugular Intrahepatic Portosystemic Stent Shunt (TIPS) in Cirrhotics With Recurrent Variceal Bleeding Non Responding to Medical Therapy Phase 4
Recruiting NCT00562445 - Adrenal Insufficiency in Critical Emergencies in Digestive Diseases N/A
Terminated NCT01383044 - Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding Phase 4
Completed NCT01060267 - Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind Trial N/A
Completed NCT00921349 - A Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis Phase 4
Recruiting NCT00966121 - Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding Phase 4
Recruiting NCT00966082 - EBL Versus EBL and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment Phase 4