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

Not Applicable

• Conditions: Esophageal and Gastric Varices
• Interventions: Procedure: monthly Endoscopic Variceal Ligation (EVL); Procedure: bi-weekly Endoscopic Variceal Ligation (EVL)

• Registration Number: NCT02719119
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-19
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-25
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05
• Primary Completion: 2017-06
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. acute or recent bleeding from esophageal varices;
2. portal hypertension caused by cirrhosis;
3. age between 18 and 80 yr.

Exclusion Criteria

1. history of endoscopic, pharmacological, interventional or surgical treatment of esophageal varices;
2. presence of liver failure with a serum total bilirubin concentration greater than 3 mg/dL;
3. presence of hepatocellular carcinoma or other malignancy;
4. an association with a cerebral vascular accident, uremia, acute coronary syndrome, or other severe illness;
5. history of gastric variceal bleeding;
6. encephalopathy of stage II or worse;
7. failure to control initial variceal bleeding;
8. death within 48 h of admission;
9. refusal to participate in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
monthly EVL	monthly Endoscopic Variceal Ligation (EVL)	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.
bi-weekly EVL	bi-weekly Endoscopic Variceal Ligation (EVL)	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.

Primary Outcome Measures

Name	Time	Method
variceal rebleeding rate	2 years

Secondary Outcome Measures

Name	Time	Method
number of sessions required to abstain variceal obliteration	2 years
gastrointestinal rebleeding rate	2 years
variceal obliteration rate	2 years
adverse events	2 years
mortality	2 years

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China