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

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01070641
• Other study ID #: RCT carvidalol vs EVBL
• Status: Recruiting
• Phase: Phase 4
• First received: February 17, 2010
• Last updated: February 17, 2010
• Start date: June 2002
• Est. completion date: July 2011

Study information

• Verified date: February 2010
• Source: Aga Khan University
• Contact: Syed Hasnain A Shah, MBBS, FRCP
• Phone: 00922134930051
• Email: hasnain.alishah[@]aku.edu
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: July 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension, Portal
• Portal Hypertension

Intervention

Drug:
• Carvedilol
Carvedilol 12.5mg QD

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

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variceal hemorrhage		one year	Yes
Secondary	death		one year	Yes