NCT03827681

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.

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Liver Cirrhoses

Interventions

Type	Name	Description
PROCEDURE	Trans Intrahepatic Portosystemic Shunt	* 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.
PROCEDURE	Self Expanding Metallic Stent	* 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device is then advanced over the guidewire into the stomach, and the distal portion of the stent delivery system is withdrawn to allow inflation of the gastric balloon.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.
DRUG	Vasoactive Agent	Vasoactive Agent

Timeline

• Start date: 2019-02-06
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2019-02-01
• Last updated: 2020-03-10

Locations

1 site across 1 country: India