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Patients of cirrhosis will be enrolled who have large esophageal varices, which have never bled. After successful screening baseline hepatic venous pressure gradient (HVPG) will be measured. Tablet carvedilol 3.125 mg BD for 1 week will be started. It will be increased to 6.25 mg BD and continued for next 7 weeks. After completion of 8 weeks the hepatic venous pressure gradient (HVPG) will again be measured to find out responders (hepatic venous pressure gradient ≥20% reduction from baseline or absolute value of hepatic venous pressure gradient <12 mm Hg) and non responders (hepatic venous pressure gradient <20% reduction).The responders will be excluded from the study while the non responders will be randomize into carvedilol+VSL#3 versus Endoscopic Variceal Ligation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol+VSL#3 | Experimental | Tablet Carvedilol 6.25 mg BD + VSL#3 |
|
| Endoscopic Variceal Ligation | Active Comparator | Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol+VSL#3 | Drug | Tablet Carvedilol 6.25 mg BD & capsule VSL#3 1 TDS for 2 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of first variceal bleeding | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 1 Year | |
| Reduction in Portal pressure | 1 Year | |
| Time to bleed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiv Kumar Sarin, MBBS, MD, DM | Institute of Liver & Biliary Sciences (ILBS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences (ILBS) | New Delhi | National Capital Territory of Delhi | 110 070 | India |
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| Endoscopic variceal ligation | Procedure | In the Endoscopic Variceal Ligation arm, Endoscopic Variceal Ligation will be performed using multibander devices by senior fully trained endoscopists or under their direct supervision. Varices will be banded starting at the gastroesophageal junction moving proximally upward in a spiral fashion. Patients will undergo Endoscopic Variceal Ligation every 3-4 weeks until eradication. Eradication is defined as the absence of varices or presence of grade I esophageal varices. Following eradication, the interval for the next endoscopy will be every 3 months to look for recurrence of varices. Endoscopic Variceal Ligation sessions would be repeated for the recurrent varices if they are sufficiently large. |
|
| 1 Years |
| Adverse events | 1 Year |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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