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

NCT ID: NCT02719119

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-02-28

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.

Conditions

Esophageal and Gastric Varices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

monthly Endoscopic Variceal Ligation (EVL)

Intervention Type: PROCEDURE

Patients in this group will underwent endoscopic variceal ligation monthly.

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.

Group Type: EXPERIMENTAL

bi-weekly Endoscopic Variceal Ligation (EVL)

Intervention Type: PROCEDURE

Patients in this group will underwent endoscopic variceal ligation bi-weekly.

Interventions

monthly Endoscopic Variceal Ligation (EVL)

Patients in this group will underwent endoscopic variceal ligation monthly.

Intervention Type: PROCEDURE

bi-weekly Endoscopic Variceal Ligation (EVL)

Patients in this group will underwent endoscopic variceal ligation bi-weekly.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

luo xuefeng

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

li yang, MD

Role: STUDY_CHAIR

department of gastroenterology

Locations

West China Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

XUEFENG LUO, MD

Role: CONTACT

luo_xuefeng@yeah.net

+862885422389

Facility Contacts

Xuefeng Luo, MD

Role: primary

+862885422389

Other Identifiers

monthly versus bi-weekly EVL

Identifier Type: -

Identifier Source: org_study_id