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Surgical procedure for the Management of Bleed in Liver Liver Disease.

A randomized controlled trial to Study the Efficacy of TIPS Versus Self Expanding Metallic Stent in the management of failure to control upper Gastrointestinal bleed or re bleed in Cirrhotics.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019621
Enrollment
50
Registered
2019-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: TIPS with vasoactive drug: The most common approach is through the right internal jugular approach. After infiltrating the puncture site with 2% lignocaine and puncturing the vein a gui

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Bleeding from non-variceal source 2. Coagulopathy related bleed 3. Bleeding from Gastric varices 4. Any malignancy including HCC 5. Main Portal vein thrombosis 6. Patients in refractory shock 7. Patients with severe cardiopulmonary disease 8. Grade 4 Hepatic encephalopathy 9. MELD > 25 10.Multiorgan failure 11.Active sepsis 12.Pregnancy 13. Failure to give consent

Design outcomes

Secondary

MeasureTime frame
Adverse events in both groupsTimepoint: 6 weeks;Decompensation in both groups in the form of ascites or Hepatic EncephalopathyTimepoint: 6 weeks;Re-bleeding in both groups for 5 days from end of therapyTimepoint: 5 days;Rebleeding in both groupsTimepoint: 6 weeks;Worsening of liver severity score in both groups.Timepoint: 6 weeks

Primary

MeasureTime frame
Survival in both groupsTimepoint: 6 weeks

Countries

India

Contacts

Public ContactDr Shushrut Singh

Institute of Liver and Biliary Sciences

shivsarin@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026