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

Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01383044

Enrollment

Registered

2011-06-28

Start date

2011-07-08

Completion date

2020-06-30

Last updated

2020-11-20

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

Conditions

Variceal Bleeding

Keywords

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

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.

Interventions

PROCEDUREEVL + carvedilol

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

DRUGcarvedilol

carvedilol 6.25mg-12.5 mg per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
patients with first bleeding	3 years	the difference of bleeding episode in both groups.

Secondary

Measure	Time frame	Description
patients with complications and mortality rates	3 years	the difference of complications & survival curve between both groups.

Countries

Taiwan

Outcome results

None listed

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