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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Portal Hypertension

Intervention / Treatment
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* Drug: Carvedilol
* Procedure: Esophageal variceal band ligation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carvedilol<br>Each patient will receive Carvedilol 12.5mg QD | Drug: Carvedilol<br>* Carvedilol 12.5mg QD<br>* Other names: carvida;|
| Active Comparator: Esophageal Variceal Band Ligation<br>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<br>* Each patient will undergo for variceal band ligation after 3 weeks till the eradication of varices<br>* Other names: EVBL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variceal hemorrhage |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CARVEDILOL, VARICEAL BAND LIGATION, PRIMARY PROPHYLAXIS