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

Esophageal and Gastric Varices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02719119
• Other study ID #: monthly versus bi-weekly EVL
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2016
• Last updated: April 4, 2017
• Start date: March 2016
• Est. completion date: February 2018

Study information

• Verified date: April 2017
• Source: West China Hospital
• Contact: XUEFENG LUO, MD
• Phone: +862885422389
• Email: luo_xuefeng[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal and Gastric Varices

Intervention

Procedure:
• monthly Endoscopic Variceal Ligation (EVL)
Patients in this group will underwent endoscopic variceal ligation monthly.
• bi-weekly Endoscopic Variceal Ligation (EVL)
Patients in this group will underwent endoscopic variceal ligation bi-weekly.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variceal rebleeding rate		2 years
Secondary	gastrointestinal rebleeding rate		2 years
Secondary	variceal obliteration rate		2 years
Secondary	number of sessions required to abstain variceal obliteration		2 years
Secondary	adverse events		2 years
Secondary	mortality		2 years