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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by E-DA Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
E-DA Hospital
ClinicalTrials.gov Identifier:
NCT01383044
First received: June 16, 2011
Last updated: June 27, 2011
Last verified: June 2011

June 16, 2011
June 27, 2011
June 2011
June 2014   (final data collection date for primary outcome measure)
patients with first bleeding [ Time Frame: 3 years ] [ Designated as safety issue: No ]
the difference of bleeding episode in both groups.
Same as current
Complete list of historical versions of study NCT01383044 on ClinicalTrials.gov Archive Site
patients with complications and mortality rates [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
the difference of complications & survival curve between both groups.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Variceal Bleeding
  • 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
  • Experimental: EVL + carvedilol
    EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
    Intervention: Procedure: EVL + carvedilol
  • Active Comparator: carvedilol
    carvedilol 6.25-12.5 mg per day
    Intervention: Drug: carvedilol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
20 Years to 75 Years
No
Taiwan
 
NCT01383044
Carvedilol
Yes
IRB, E-DA Hospital
E-DA Hospital
Not Provided
Not Provided
E-DA Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP