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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Aga Khan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT01070641
First received: February 17, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Portal Hypertension
Drug: Carvedilol
Procedure: Esophageal variceal band ligation
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: RCT of Carvedilol vs Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Variceal hemorrhage [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • death [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 148
Study Start Date: June 2002
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Carvedilol
Each patient will receive Carvedilol 12.5mg QD
Drug: Carvedilol
Carvedilol 12.5mg QD
Other Name: carvida
Active Comparator: Esophageal Variceal Band Ligation
Each patient will undergo for serial esophageal variceal band ligations after 3 weeks of last session till the eradication of varices
Procedure: Esophageal variceal band ligation
Each patient will undergo for variceal band ligation after 3 weeks till the eradication of varices
Other Name: EVBL

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070641

Contacts
Contact: Syed Hasnain A Shah, MBBS, FRCP 00922134930051 ext 4676 hasnain.alishah@aku.edu

Locations
Pakistan
Aga Khan University Hospital Recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Syed Hasnain A Shah, MBBS, FRCP    00922134930051 ext 4676    hasnail.alishah@aku.edu   
Principal Investigator: Syed Hasnain A Shah, FRCP         
Sub-Investigator: Amna Butt, MBBS, FCPS         
Sub-Investigator: Ambreen Pyarali, MBBS         
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Syed hasnain A Shah, MBBS, FRCP Aga Khan University Hospital, Karachi
  More Information

No publications provided

Responsible Party: Syed hasnain Ali Shah, Aga Khan University Hospital, Karachi
ClinicalTrials.gov Identifier: NCT01070641     History of Changes
Other Study ID Numbers: RCT carvidalol vs EVBL
Study First Received: February 17, 2010
Last Updated: February 17, 2010
Health Authority: Pakistan: Research Ethics Committee
United States: Food and Drug Administration

Keywords provided by Aga Khan University:
CARVEDILOL
VARICEAL BAND LIGATION
PRIMARY PROPHYLAXIS

Additional relevant MeSH terms:
Hypertension
Hemorrhage
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
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 September 18, 2014