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

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 Overview

• Status: Unknown
• Conditions: Esophageal and Gastric Varices
• Intervention / Treatment: Procedure: monthly Endoscopic Variceal Ligation (EVL); Procedure: bi-weekly Endoscopic Variceal Ligation (EVL)

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: XUEFENG LUO, MD; Phone Number: +862885422389; Email: luo_xuefeng@yeah.net

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital
      • Contact: Xuefeng Luo, MD; Phone Number: +862885422389

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: monthly 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.	Procedure: monthly Endoscopic Variceal Ligation (EVL); Patients in this group will underwent endoscopic variceal ligation monthly.
Experimental: bi-weekly 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.	Procedure: bi-weekly Endoscopic Variceal Ligation (EVL); Patients in this group will underwent endoscopic variceal ligation bi-weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
variceal rebleeding rate	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Chair: li yang, MD, Department of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: March 19, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices
• Other Study ID Numbers: monthly versus bi-weekly EVL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided