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

Primary Purpose

Variceal Bleeding

Status
Terminated
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
EVL + carvedilol
carvedilol
Sponsored by
E-DA Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Variceal Bleeding focused on measuring Carvedilol, Banding ligation with Carvedilol, the efficacy & safety of combining EVL and carvedilol in prevention of first variceal bleeding

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • E-DA hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EVL + carvedilol

carvedilol

Arm Description

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

carvedilol 6.25-12.5 mg per day

Outcomes

Primary Outcome Measures

patients with first bleeding
the difference of bleeding episode in both groups.

Secondary Outcome Measures

patients with complications and mortality rates
the difference of complications & survival curve between both groups.

Full Information

First Posted
June 16, 2011
Last Updated
November 19, 2020
Sponsor
E-DA Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01383044
Brief Title
Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding
Official Title
Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
July 8, 2011 (Actual)
Primary Completion Date
July 30, 2015 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
E-DA Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Variceal Bleeding
Keywords
Carvedilol, Banding ligation with Carvedilol, the efficacy & safety of combining EVL and carvedilol in prevention of first variceal bleeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVL + carvedilol
Arm Type
Experimental
Arm Description
EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
Arm Title
carvedilol
Arm Type
Active Comparator
Arm Description
carvedilol 6.25-12.5 mg per day
Intervention Type
Procedure
Intervention Name(s)
EVL + carvedilol
Intervention Description
EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
Intervention Type
Drug
Intervention Name(s)
carvedilol
Intervention Description
carvedilol 6.25mg-12.5 mg per day
Primary Outcome Measure Information:
Title
patients with first bleeding
Description
the difference of bleeding episode in both groups.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
patients with complications and mortality rates
Description
the difference of complications & survival curve between both groups.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cirrhosis with esophageal varices are larger than F2. No history of variceal bleeding. In three months have not implemented preventive esophageal variceal ligation. (4)age 20yrs～75yrs. Exclusion Criteria: Association with HCC or other cancers . Refractory ascites. Jaundice, bilirubin > 5mg/dl. Encephalopathy. Cr.>3mg/dL. A-V,block bradycardia (PR < 60/mim). Hypotension systolic blood pressure<95/mmHg . Refusal to participate. Carvedilol allergy Second degree-third degree Atrio-ventricular block. Bradycardia. WPWsyndrome Hypotension Psychogenic shock. Asthma. All the patients are randomized based on a random number.
Facility Information:
Facility Name
E-DA hospital
City
Kaogsiung
ZIP/Postal Code
82445
Country
Taiwan

12. IPD Sharing Statement

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

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