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Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding

NCT ID: NCT01383044

Last Updated: 2020-11-20

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-08

Study Completion Date

2020-06-30

Brief Summary

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Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. The efficacy \& safety of combining EVL and carvedilol in prophylaxis of the first bleeding is still unknown. This study aims to investigate the value of combination therapy.

Detailed Description

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Combination of EVL and β-blocker has been proven effective in the prevention of variceal rebleeding . However, Our previous study showed that combination of EVL and nadolol do not have enhanced effect in the prophylaxis of 1st variceal bleeding as compared with nadolol alone . One of the drawbacks of EVL is esophageal ulcer. On the other hand ,carvedilol, an anti-α beta-blocker, has been proven to be more effective than propranolol in the reduction of portal pressure. Carvedilol has been proven to be more effective than EVL in the prevention of 1st variceal bleeding. The investigators thus conduct a multicenter trial to evaluate whether combination of EVL and carvedilol could be more effective than carvedilol alone in the prophylaxis of 1st esophageal variceal bleeding . The goal of patients receiving EVL is to reduce variceal size, not variceal obliteration, in anticipation for fewer sessions required for each patient and fewer possibility of esophageal ulcer bleeding.

Conditions

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Variceal Bleeding

Keywords

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Carvedilol Banding ligation with Carvedilol the efficacy & safety of combining EVL and carvedilol in prevention of first variceal bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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EVL + carvedilol

EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day

Group Type EXPERIMENTAL

EVL + carvedilol

Intervention Type PROCEDURE

EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day

carvedilol

carvedilol 6.25-12.5 mg per day

Group Type ACTIVE_COMPARATOR

carvedilol

Intervention Type DRUG

carvedilol 6.25mg-12.5 mg per day

Interventions

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EVL + carvedilol

EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day

Intervention Type PROCEDURE

carvedilol

carvedilol 6.25mg-12.5 mg per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Cirrhosis with esophageal varices are larger than F2.
2. No history of variceal bleeding.
3. In three months have not implemented preventive esophageal variceal ligation. (4)age 20yrs～75yrs.

Exclusion Criteria

1. Association with HCC or other cancers .
2. Refractory ascites.
3. Jaundice, bilirubin \> 5mg/dl.
4. Encephalopathy.
5. Cr.\>3mg/dL.
6. A-V,block bradycardia (PR \< 60/mim).
7. Hypotension systolic blood pressure\<95/mmHg .
8. Refusal to participate.
9. Carvedilol allergy
10. Second degree-third degree Atrio-ventricular block.
11. Bradycardia.
12. WPWsyndrome
13. Hypotension
14. Psychogenic shock.
15. Asthma. All the patients are randomized based on a random number.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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E-DA Hospital

OTHER

Sponsor Role lead

Responsible Party

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E-DA Hospital

Locations

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E-DA hospital

Kaogsiung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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Carvedilol

Identifier Type: -

Identifier Source: org_study_id