Back to resultsTrial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
Primary Purpose
Esophageal and Gastric Varices
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
monthly Endoscopic Variceal Ligation (EVL)
bi-weekly Endoscopic Variceal Ligation (EVL)
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal and Gastric Varices
Eligibility Criteria
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.
Sites / Locations
- West China HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
monthly EVL
bi-weekly EVL
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
variceal rebleeding rate
Secondary Outcome Measures
gastrointestinal rebleeding rate
variceal obliteration rate
number of sessions required to abstain variceal obliteration
adverse events
mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02719119
Brief Title
Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
Official Title
Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal and Gastric Varices
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
monthly EVL
Arm Type
Experimental
Arm Description
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.
Arm Title
bi-weekly EVL
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
monthly Endoscopic Variceal Ligation (EVL)
Intervention Description
Patients in this group will underwent endoscopic variceal ligation monthly.
Intervention Type
Procedure
Intervention Name(s)
bi-weekly Endoscopic Variceal Ligation (EVL)
Intervention Description
Patients in this group will underwent endoscopic variceal ligation bi-weekly.
Primary Outcome Measure Information:
Title
variceal rebleeding rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
gastrointestinal rebleeding rate
Time Frame
2 years
Title
variceal obliteration rate
Time Frame
2 years
Title
number of sessions required to abstain variceal obliteration
Time Frame
2 years
Title
adverse events
Time Frame
2 years
Title
mortality
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XUEFENG LUO, MD
Phone
+862885422389
Email
luo_xuefeng@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li yang, MD
Organizational Affiliation
department of gastroenterology
Official's Role
Study Chair
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefeng Luo, MD
Phone
+862885422389
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
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