Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Pre-emptive TIPSS plus Standard Medical Therapy: These patients will undergo pre-emptive TIPSS within 72 hours of admission for index bleed. After the procedure, patients will be starte
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients with upper GI bleed originating from esophageal varices seen on endoscopy satisfying the following criteria a) Child Class B (Score 7 and above) with active bleeding from the varices seen on endoscopy b) Any patient belonging to Child Class C (score 2. Age between 18-65 years 3. Willing to participate in the study
Exclusion criteria
Exclusion criteria: 1. Failure to control bleed (primary hemostasis) 2. Patients belonging to Child Class A 3. Non-cirrhotic causes of portal hypertension 4. Hepatocellular carcinoma 5. Portal vein thrombosis/Portal cavernoma 6. Contraindications to beta-blockers- hypotension on beta blockers, uncontrolled asthma 7. Contraindications to TIPSS (provided in table below) 8. Active sepsis with or without septic shock 9. Underlying cardiopulmonary disease (ECHO) 10. Prior TIPSS 11. Chronic Kidney Disease or Acute Kidney Injury with serum creatinine >3.0 mg/dl 12. HE Grade 1 and above/or past history of recurrent HE ( >1 episode) 13. Pregnant women 14. Any underlying malignancy 15. Denied consent for participation Contraindications to TIPSS Ejection fraction Uncontrolled sepsis or septic shock Biliary malignancies Severe pulmonary hypertension (mean pulmonary arterial pressures >40 mm of Hg) Portal vein thrombosis Platelets <20,000/cu.mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comparison of survival rates at 1 year between the 2 arms (SMT vs p-TIPSS).Timepoint: 1. 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. To assess the complications ascites/HE at 1, 3, 6 and 12 months between the 2 armsTimepoint: 3. 1,3,6,12 months;Comparative cost assessment between the two groups.Timepoint: baseline and 1 year;To assess the difference in the overall and EV bleed related mortality at 1,3,6, and 12 monthsTimepoint: 1,3,6,12 months;To assess the differences in rebleeding rates at 5 days 6 weeks and 1 year between the armsTimepoint: 5 days 6 weeks 1 year;To assess the differences in the delta changes in MELD and CTP scores at 1, 3, 6, and 12 months between the 2 armsTimepoint: 1, 3, 6, 12 months;To assess the differences in the rate of EV obliteration between the 2 armsTimepoint: 1,3,6,12 months | — |
Countries
India
Contacts
Public ContactDr DrShalimar
All India Institute of Medical Sciences
Outcome results
None listed