Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Esophageal and Gastric Varices
- Sponsor
- West China Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- variceal rebleeding rate
- Last Updated
- 9 years ago
Overview
Brief Summary
Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.
Detailed Description
Endoscopic variceal ligation (EVL) is a safe and simple procedure now being used on a widening scale. A lot of patients who undergo endoscopic treatment for esophageal varices eventually require additional treatment for recurrent varices. Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.
Investigators
luo xuefeng
MD
West China Hospital
Eligibility Criteria
Inclusion Criteria
- •acute or recent bleeding from esophageal varices;
- •portal hypertension caused by cirrhosis;
- •age between 18 and 80 yr.
Exclusion Criteria
- •history of endoscopic, pharmacological, interventional or surgical treatment of esophageal varices;
- •presence of liver failure with a serum total bilirubin concentration greater than 3 mg/dL;
- •presence of hepatocellular carcinoma or other malignancy;
- •an association with a cerebral vascular accident, uremia, acute coronary syndrome, or other severe illness;
- •history of gastric variceal bleeding;
- •encephalopathy of stage II or worse;
- •failure to control initial variceal bleeding;
- •death within 48 h of admission;
- •refusal to participate in the trial.
Outcomes
Primary Outcomes
variceal rebleeding rate
Time Frame: 2 years
Secondary Outcomes
- gastrointestinal rebleeding rate(2 years)
- number of sessions required to abstain variceal obliteration(2 years)
- variceal obliteration rate(2 years)
- adverse events(2 years)
- mortality(2 years)