EBL Versus EBL and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2021-07-31

Brief Summary

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This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

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Detailed Description

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Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. In addition, most of all recent studies included patients without previous endoscopic treatment for varices. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Conditions

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Cirrhosis Variceal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Endoscopic band ligation

Perform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval

Group Type ACTIVE_COMPARATOR

endoscopic band ligation

Intervention Type PROCEDURE

Perform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval

endoscopic band ligation+Propranolol

Perform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval, with propranolol

Group Type ACTIVE_COMPARATOR

endoscopic band ligation+Propranolol

Intervention Type PROCEDURE

Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min

Interventions

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endoscopic band ligation

Perform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval

Intervention Type PROCEDURE

endoscopic band ligation+Propranolol

Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Liver cirrhosis
* Age between 18 and 70 years
* Successful control of esophageal variceal bleeding within 6 weeks before enrollment

Exclusion Criteria

* Gastric variceal bleeding
* Patients with systolic blood pressure \<100 mmHg or basal heart rate \<60/min
* Portal vein thrombosis
* Prominent hepatic encephalopathy
* Coexisting untreated malignancy
* Severe cerebrovascular or cardiovascular disease, renal failure
* No previous history of endoscopic, radiologic, or surgical treatment for varices or ascites
* Contraindication to beta-blocker
* Pregnancy
* Refusal to give consent to participate in the trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No