Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding

Conditions
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Esophageal and Gastric Varices

Intervention / Treatment
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* Procedure: monthly Endoscopic Variceal Ligation (EVL)
* Procedure: bi-weekly Endoscopic Variceal Ligation (EVL)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: monthly EVL<br>Elective band ligation was applied after premedication with hyoscine-N-butylbromide (20 mg intramuscularly). A multiband ligator and video endoscopes were utilized. Ligation was initiated at or slightly below the bleeding point. During each treatment session, each varix was ligated with one or two elastic bands. Variceal obliteration success was when all varices disappeared or residual varices were too small to be ligated further. Once esophageal varices were obliterated, surveillance endoscopy was performed every 3 months for 1 year and then every 6 months to check for recurrent varices. Patients in this group will underwent endoscopic variceal ligation monthly. | Procedure: monthly Endoscopic Variceal Ligation (EVL)<br>* Patients in this group will underwent endoscopic variceal ligation monthly.<br>|
| Experimental: bi-weekly EVL<br>Elective band ligation was applied after premedication with hyoscine-N-butylbromide (20 mg intramuscularly). A multiband ligator and video endoscopes were utilized. Ligation was initiated at or slightly below the bleeding point. During each treatment session, each varix was ligated with one or two elastic bands. Variceal obliteration success was when all varices disappeared or residual varices were too small to be ligated further. Once esophageal varices were obliterated, surveillance endoscopy was performed every 3 months for 1 year and then every 6 months to check for recurrent varices. Patients in this group will underwent endoscopic variceal ligation bi-weekly. | Procedure: bi-weekly Endoscopic Variceal Ligation (EVL)<br>* Patients in this group will underwent endoscopic variceal ligation bi-weekly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variceal rebleeding rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastrointestinal rebleeding rate |  | 2 years | 
| variceal obliteration rate |  | 2 years | 
| number of sessions required to abstain variceal obliteration |  | 2 years | 
| adverse events |  | 2 years | 
| mortality |  | 2 years |