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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol+EVL | Experimental |
| |
| Carvedilol | Experimental |
| |
| EVL | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the incidence of first variceal bleed at 1 year. | 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39067870 | Derived | Tevethia HV, Pande A, Vijayaraghavan R, Kumar G, Sarin SK. Combination of carvedilol with variceal band ligation in prevention of first variceal bleed in Child-Turcotte-Pugh B and C cirrhosis with high-risk oesophageal varices: the 'CAVARLY TRIAL'. Gut. 2024 Oct 7;73(11):1844-1853. doi: 10.1136/gutjnl-2023-331181. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Endoscopic Variceal Ligation | Procedure | EVL will be done every 3 weeks till eradication |
|
| 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 |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |