RCT of Carvedilol Versus Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage
Recruitment status was: Recruiting
Aim To compare Carvedilol with variceal band ligation in the prevention of first variceal bleed.
End points of trial Primary: Variceal hemorrhage Secondary: Death
Randomised controlled clinical trial. Results analysed for the above end points on an intention-to-treat basis.
|Portal Hypertension||Drug: Carvedilol Procedure: Esophageal variceal band ligation||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||RCT of Carvedilol vs Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage|
- Variceal hemorrhage [ Time Frame: one year ]
- death [ Time Frame: one year ]
|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)|
Active Comparator: Carvedilol
Each patient will receive Carvedilol 12.5mg QD
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070641
|Contact: Syed Hasnain A Shah, MBBS, FRCP||00922134930051 ext email@example.com|
|Aga Khan University Hospital||Recruiting|
|Karachi, Sindh, Pakistan, 74800|
|Contact: Syed Hasnain A Shah, MBBS, FRCP 00922134930051 ext 4676 firstname.lastname@example.org|
|Principal Investigator: Syed Hasnain A Shah, FRCP|
|Sub-Investigator: Amna Butt, MBBS, FCPS|
|Sub-Investigator: Ambreen Pyarali, MBBS|
|Principal Investigator:||Syed hasnain A Shah, MBBS, FRCP||Aga Khan University Hospital, Karachi|