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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02719119
Enrollment
60
Registered
2016-03-25
Start date
2016-03-31
Completion date
2018-02-28
Last updated
2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal and Gastric Varices

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.

Interventions

PROCEDUREmonthly Endoscopic Variceal Ligation (EVL)

Patients in this group will underwent endoscopic variceal ligation monthly.

PROCEDUREbi-weekly Endoscopic Variceal Ligation (EVL)

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

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
variceal rebleeding rate2 years

Secondary

MeasureTime frame
gastrointestinal rebleeding rate2 years
variceal obliteration rate2 years
number of sessions required to abstain variceal obliteration2 years
adverse events2 years
mortality2 years

Countries

China

Contacts

Primary ContactXUEFENG LUO, MD
luo_xuefeng@yeah.net+862885422389

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026