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A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or Group B (SEMS).
Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival at 6 week or Early re Bleed. All enrolled patients will also undergo HVPG measurement at baseline to stratify risk of failure to control bleed or early re-bleed.
Patient will be monitored for 5 days for re bleed, complications of therapy, worsening of Liver function tests and scores and efficacy of either treatment modality over other. Patient will be followed for 6 weeks to see for the primary end point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIPS + Vasoactive Drug | Experimental |
| |
| SEMS + Vasoactive Drug | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans Intrahepatic Portosystemic Shunt | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival in both groups | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Re-bleeding in both groups for 5 days from end of therapy | 5 days | |
| Rebleeding in both groups | 6 weeks | |
| Decompensation in both groups in the form of ascites or Hepatic Encephalopathy |
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Inclusion Criteria:
- Consecutive patients of cirrhosis aged 18-70 years presenting with acute variceal Bleeding, who on endoscopy fail to control bleed or rebleeds within 5 days will be randomized.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Shushrut Singh, MD | Contact | 01146300000 | drsushrut20@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40631454 | Derived | Singh S, Arora V, Maiwall R, Mukund A, Jindal A, Choudhry A, Kumar G, Sarin SK. TIPS Is Superior to SEMS in the Management of Refractory VARICEAL Bleed in Advanced Cirrhosis Patients (TIPSEMS-VB Trial). Liver Int. 2025 Aug;45(8):e70178. doi: 10.1111/liv.70178. |
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|
| Self Expanding Metallic Stent | Procedure |
|
|
| Vasoactive Agent | Drug | Vasoactive Agent |
|
| 6 weeks |
| Adverse events in both groups | 6 weeks |
| Worsening of liver severity score in both groups. | 6 weeks |
| ID | Term |
|---|---|
| D014662 | Vasoconstrictor Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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