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

NCT ID: NCT01070641

Last Updated: 2010-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2011-07-31

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.

Conditions

Portal Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Carvedilol

Each patient will receive Carvedilol 12.5mg QD

Group Type: ACTIVE_COMPARATOR

Carvedilol

Intervention Type: DRUG

Carvedilol 12.5mg QD

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

Group Type: ACTIVE_COMPARATOR

Esophageal variceal band ligation

Intervention Type: PROCEDURE

Each patient will undergo for variceal band ligation after 3 weeks till the eradication of varices

Interventions

Carvedilol

Carvedilol 12.5mg QD

Intervention Type: DRUG

Esophageal variceal band ligation

Each patient will undergo for variceal band ligation after 3 weeks till the eradication of varices

Intervention Type: PROCEDURE

Other Intervention Names

carvida; EVBL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Aga Khan University Hospital, Karachi

Principal Investigators

Syed hasnain A Shah, MBBS, FRCP

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University Hospital, Karachi

Locations

Aga Khan University Hospital

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Syed Hasnain A Shah, MBBS, FRCP

Role: CONTACT

hasnain.alishah@aku.edu

00922134930051 ext. 4676

Facility Contacts

Syed Hasnain A Shah, MBBS, FRCP

Role: primary

hasnail.alishah@aku.edu

00922134930051 ext. 4676

Other Identifiers

RCT carvidalol vs EVBL

Identifier Type: -

Identifier Source: org_study_id