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

Aga Khan University

Status and phase: Unknown; Phase 4

Conditions: Portal Hypertension

Treatments: Drug: Carvedilol; Procedure: Esophageal variceal band ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT01070641

RCT carvidalol vs EVBL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Carvedilol

Active Comparator group

Description:

Each patient will receive Carvedilol 12.5mg QD

Treatment:

Drug: Carvedilol

Esophageal Variceal Band Ligation

Active Comparator group

Description:

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

Treatment:

Procedure: Esophageal variceal band ligation