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

This study is currently recruiting participants.
Verified June 2011 by E-DA Hospital
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Variceal Bleeding
 Procedure: EVL + carvedilol
Drug: carvedilol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices

Resource links provided by NLM:

Drug Information available for: Carvedilol
U.S. FDA Resources

Further study details as provided by E-DA Hospital:

Primary Outcome Measures:
  • patients with first bleeding [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    the difference of bleeding episode in both groups.


Secondary Outcome Measures:
  • patients with complications and mortality rates [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    the difference of complications & survival curve between both groups.


Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EVL + carvedilol
EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
 Procedure: EVL + carvedilol
EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
Active Comparator: carvedilol
carvedilol 6.25-12.5 mg per day
 Drug: carvedilol
carvedilol 6.25mg-12.5 mg per day

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383044

Locations
Taiwan
E-DA hospital Recruiting
Kaogsiung, Taiwan, 82445
Contact: Gin Ho Lo, MD     0975106248        
Sponsors and Collaborators
E-DA Hospital
  More Information

No publications provided

Responsible Party: IRB, E-DA Hospital
ClinicalTrials.gov Identifier: NCT01383044     History of Changes
Other Study ID Numbers: Carvedilol
Study First Received: June 16, 2011
Last Updated: June 27, 2011
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by E-DA Hospital:
Carvedilol
Banding ligation with Carvedilol
the efficacy & safety of combining EVL and carvedilol in prevention of first variceal bleeding

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on May 19, 2013