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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Liver Cirrhoses

Intervention / Treatment
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* Procedure: Trans Intrahepatic Portosystemic Shunt
* Procedure: Self Expanding Metallic Stent
* Drug: Vasoactive Agent


Participation Criteria
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Eligibility Criteria
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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: Bleeding from non-variceal source Coagulopathy related bleed Bleeding from Gastric varices Any malignancy including HCC Main Portal vein thrombosis Patients in refractory shock Patients with severe cardiopulmonary disease Grade 4 Hepatic encephalopathy MELD > 25 Multiorgan failure Active sepsis Pregnancy Failure to give consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIPS + Vasoactive Drug<br> | Procedure: Trans Intrahepatic Portosystemic Shunt<br>* The most common approach is through the right internal jugular approach. After infiltrating the puncture site with 2% lignocaine and puncturing the vein a guide wire is advanced into the IVC followed by a 9F/10F vascular sheath. A wedged venogram is performed with a peripherally placed hepatic vein catheter, which may identify a portion of the portal vein to facilitate subsequent puncture.' A stiff guide wire is then passed through the catheter and the vascular sheath is advanced into the right hepatic vein. With the vascular sheath in place a rigid needle with 15-20 degrees of distal angulation is advanced over the guide wire and through the vascular sheath to enter the hepatic vein.<br>Drug: Vasoactive Agent<br>* Vasoactive Agent<br>|
| Active Comparator: SEMS + Vasoactive Drug<br> | Procedure: Self Expanding Metallic Stent<br>* At upper endoscopy, a 0.35 Superstiff radiological guidewire with a soft tip (supplied with the stent insertion kit) is delivered into the stomach under direct vision and the endoscope is removed. The stent delivery device is then advanced over the guidewire into the stomach, and the distal portion of the stent delivery system is withdrawn to allow inflation of the gastric balloon. The gastric balloon is then inflated with 100 mL of air, and the whole delivery system is withdrawn until resistance is felt, which signifies that the balloon is impacting at the cardia, thus anchoring the distal end of the stent during deployment. After stent deployment, the gastric balloon is deflated and the stent delivery system is withdrawn. The stent is then examined endoscopically. When deployed, the stent is 135 mm long and 25 mm wide.<br>Drug: Vasoactive Agent<br>* Vasoactive Agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival in both groups |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 6 weeks | 
| Adverse events in both groups |  | 6 weeks | 
| Worsening of liver severity score in both groups. |  | 6 weeks |