Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis

Study Overview
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Brief Summary
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Study Design: Open labeled randomized controlled trial. The study will be conducted on patients attending outpatient or admitted to admitted to Department of Hepatology from January 2017 to December 2018 at ILBS, New Delhi

Official Title
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Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis: A Randomized Controlled Trial

Conditions
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Cirrhosis

Intervention / Treatment
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* Drug: Carvedilol
* Procedure: Endoscopic Variceal Ligation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver Cirrhotics between 18-70 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan & imaging.) CTP ≥ 7-15 (Child's B/C) Small esophageal varices with RCS and large esophageal varices (>5 mm) No history of previous bleed Exclusion Criteria: Malignancy-HCC, PVT Child A MELD >35 Contraindications to β blockers. Platelet count < 30,000/mm3 Previous endoscopic variceal treatment. (Beyond 21 days) Patients having an indication for TIPS or requiring more than 1 therapeutic ascitic tapping/month Post TIPS, Shunt surgery Acute kidney injury (Sr.Cr>1.5mg/dl) Non cirrhotic portal hypertension Acute on chronic liver failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carvedilol+EVL<br> | Drug: Carvedilol<br>* Carvedilol will start at starting dose of 3.125 mg BD followed by 6.25 mg BD followed by 12.5 mg BD if BP 90/60 mmHg and HR 55/min<br>Procedure: Endoscopic Variceal Ligation<br>* EVL will be done every 3 weeks till eradication<br>|
| Experimental: Carvedilol<br> | Drug: Carvedilol<br>* Carvedilol will start at starting dose of 3.125 mg BD followed by 6.25 mg BD followed by 12.5 mg BD if BP 90/60 mmHg and HR 55/min<br>|
| Active Comparator: EVL<br> | Procedure: Endoscopic Variceal Ligation<br>* EVL will be done every 3 weeks till eradication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the incidence of first variceal bleed at 1 year. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall and bleed related Survival in all the 3 groups |  | 1 year | 
| Bleed related Survival in all the 3 groups |  | 1 year | 
| Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groups |  | 1 year | 
| Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groups |  | 1 year | 
| Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups |  | 1 year | 
| Incidence of Acute Kidney Injury (AKI) in all the 3 groups |  | 1 year | 
| Incidence of Shock in all the 3 groups |  | 1 year | 
| Incidence of new ascites in all the 3 groups |  | 1 year | 
| HVPG response at 1year in all the 3 groups |  | 1 year | 
| Treatment related side effects in all the 3 groups |  | 1 year |