To Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.
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|ClinicalTrials.gov Identifier: NCT03827681|
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : March 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhoses||Procedure: Trans Intrahepatic Portosystemic Shunt Procedure: Self Expanding Metallic Stent Drug: Vasoactive Agent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial to Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.|
|Actual Study Start Date :||February 6, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
|Experimental: TIPS + Vasoactive Drug||
Procedure: Trans Intrahepatic Portosystemic Shunt
Drug: Vasoactive Agent
|Active Comparator: SEMS + Vasoactive Drug||
Procedure: Self Expanding Metallic Stent
Drug: Vasoactive Agent
- Survival in both groups [ Time Frame: 6 weeks ]
- Re-bleeding in both groups for 5 days from end of therapy [ Time Frame: 5 days ]
- Rebleeding in both groups [ Time Frame: 6 weeks ]
- Decompensation in both groups in the form of ascites or Hepatic Encephalopathy [ Time Frame: 6 weeks ]
- Adverse events in both groups [ Time Frame: 6 weeks ]
- Worsening of liver severity score in both groups. [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827681
|Contact: Dr Shushrut Singh, MDfirstname.lastname@example.org|
|Institute of Liver & Biliary Sciences||Recruiting|
|New Delhi, Delhi, India, 110070|
|Contact: Dr Shushrut Singh, MD|