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

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ClinicalTrials.gov Identifier: NCT01383044
Recruitment Status : Unknown
Verified June 2011 by E-DA Hospital.
Recruitment status was:  Recruiting
First Posted : June 28, 2011
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Variceal Bleeding Procedure: EVL + carvedilol Drug: carvedilol Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices
Study Start Date : June 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. patients with first bleeding [ Time Frame: 3 years ]
    the difference of bleeding episode in both groups.


Secondary Outcome Measures :
  1. patients with complications and mortality rates [ Time Frame: 3 years ]
    the difference of complications & survival curve between both groups.



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383044


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

Responsible Party: IRB, E-DA Hospital
ClinicalTrials.gov Identifier: NCT01383044     History of Changes
Other Study ID Numbers: Carvedilol
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

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
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists