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

Phase 4

Terminated

• Conditions: Variceal Bleeding
• Interventions: Procedure: EVL + carvedilol; Drug: carvedilol

• Registration Number: NCT01383044
• Lead Sponsor: E-DA Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Study Start: 2011-07-08
• Primary Completion: 2015-07-30
• Study Completion: 2020-06-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVL + carvedilol	EVL + carvedilol	EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
carvedilol	carvedilol	carvedilol 6.25-12.5 mg per day

Primary Outcome Measures

Name	Time	Method
patients with first bleeding	3 years	the difference of bleeding episode in both groups.

Secondary Outcome Measures

Name	Time	Method
patients with complications and mortality rates	3 years	the difference of complications \& survival curve between both groups.

Trial Locations

Locations (1)

E-DA hospital; 🇨🇳 Kaogsiung, Taiwan