The management of acute variceal bleeding in patients with liver cirrhosis at high risk of rebleeding with early placement of stent in the liver versus optimized medical therapy.
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2023/11/059817
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 < 13)
2. Age between 18-65 years
3. Willing to participate in the study
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 <45 %
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Comparison of survival rates at 1 year between the 2 arms (SMT vs p-TIPSS).Timepoint: 1. 1 year
- Secondary Outcome Measures
Name Time Method 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