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RCT of Carvedilol Versus Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage

Primary Purpose

Portal Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Carvedilol
Esophageal variceal band ligation
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Portal Hypertension focused on measuring CARVEDILOL, VARICEAL BAND LIGATION, PRIMARY PROPHYLAXIS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.

Exclusion Criteria:

  • Age <18 or > 75 years.
  • Pregnant or lactating patients: patients of childbearing age who are not on contraception.
  • Allergy to Carvedilol.
  • Already on beta blockers or nitrates.
  • Presence of malignancy that will significantly affect survival.
  • Presence of severe systemic illness e.g. cardiorespiratory, active sepsis.
  • Psychiatric disease or learning difficulty that will prevent the granting of informed consent.
  • Presence of obstructive airways disease.

Sites / Locations

  • Aga Khan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Carvedilol

Esophageal Variceal Band Ligation

Arm Description

Each patient will receive Carvedilol 12.5mg QD

Each patient will undergo for serial esophageal variceal band ligations after 3 weeks of last session till the eradication of varices

Outcomes

Primary Outcome Measures

Variceal hemorrhage

Secondary Outcome Measures

death

Full Information

First Posted
February 17, 2010
Last Updated
February 17, 2010
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT01070641
Brief Title
RCT of Carvedilol Versus Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage
Official Title
RCT of Carvedilol vs Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Aga Khan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aim To compare Carvedilol with variceal band ligation in the prevention of first variceal bleed. End points of trial Primary: Variceal hemorrhage Secondary: Death Study design Randomised controlled clinical trial. Results analysed for the above end points on an intention-to-treat basis.
Detailed Description
Patients from the Gastroenterology section of the Aga Khan University, Karachi, with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices. Method All suitable patients will be recruited after informed consent is given. Randomisation of treatment is by sealed envelopes prepared in batches of 20. Carvedilol This will be administered as a once daily dose of 12.5mg. Variceal band ligation Endoscopy will be performed ever two weeks until eradication of oesophageal varices. Eradication is achieved when no varices or only grade I varices (varices which are small and flatten on air insufflations in the oesophagus) are present. Subsequent endoscopy sessions will be progressively less frequent, at intervals of 3 months, 6 months and 12 months thereafter. Should varices recur, the protocol for eradication as described above will be re-instituted. Follow-up This will take place in a dedicated clinic. First visit is six weeks after initiation of treatment and three monthly thereafter. Clinical and laboratory parameters will be obtained at each visit. All patients with alcoholic liver disease will be asked to provide an up-to-date status on drinking. Treatment will cease upon reaching any of these end-points: variceal haemorrhage, death or liver transplantation. Duration of follow-up is defined as time from randomisation to the above end points or to the last follow-up date available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension
Keywords
CARVEDILOL, VARICEAL BAND LIGATION, PRIMARY PROPHYLAXIS

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Carvedilol
Arm Type
Active Comparator
Arm Description
Each patient will receive Carvedilol 12.5mg QD
Arm Title
Esophageal Variceal Band Ligation
Arm Type
Active Comparator
Arm Description
Each patient will undergo for serial esophageal variceal band ligations after 3 weeks of last session till the eradication of varices
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
carvida
Intervention Description
Carvedilol 12.5mg QD
Intervention Type
Procedure
Intervention Name(s)
Esophageal variceal band ligation
Other Intervention Name(s)
EVBL
Intervention Description
Each patient will undergo for variceal band ligation after 3 weeks till the eradication of varices
Primary Outcome Measure Information:
Title
Variceal hemorrhage
Time Frame
one year
Secondary Outcome Measure Information:
Title
death
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices. Exclusion Criteria: Age <18 or > 75 years. Pregnant or lactating patients: patients of childbearing age who are not on contraception. Allergy to Carvedilol. Already on beta blockers or nitrates. Presence of malignancy that will significantly affect survival. Presence of severe systemic illness e.g. cardiorespiratory, active sepsis. Psychiatric disease or learning difficulty that will prevent the granting of informed consent. Presence of obstructive airways disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Syed Hasnain A Shah, MBBS, FRCP
Phone
00922134930051
Ext
4676
Email
hasnain.alishah@aku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed hasnain A Shah, MBBS, FRCP
Organizational Affiliation
Aga Khan University Hospital, Karachi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed Hasnain A Shah, MBBS, FRCP
Phone
00922134930051
Ext
4676
Email
hasnail.alishah@aku.edu
First Name & Middle Initial & Last Name & Degree
Syed Hasnain A Shah, FRCP
First Name & Middle Initial & Last Name & Degree
Amna Butt, MBBS, FCPS
First Name & Middle Initial & Last Name & Degree
Ambreen Pyarali, MBBS

12. IPD Sharing Statement

Learn more about this trial

RCT of Carvedilol Versus Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage

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