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

Variceal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01383044
• Other study ID #: Carvedilol
• Status: Terminated
• Phase: Phase 4
• Start date: July 8, 2011
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2020
• Source: E-DA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: June 30, 2020
• Est. primary completion date: July 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Variceal Bleeding

Intervention

Procedure:
• EVL + carvedilol
EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day

Drug:
• carvedilol
carvedilol 6.25mg-12.5 mg per day

Locations

Country	Name	City	State
Taiwan	E-DA hospital	Kaogsiung

Sponsors (1)

Lead Sponsor	Collaborator
E-DA Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients with first bleeding	the difference of bleeding episode in both groups.	3 years
Secondary	patients with complications and mortality rates	the difference of complications & survival curve between both groups.	3 years