An interventional study of Trans Intrahepatic Portosystemic Shunt and Self Expanding Metallic Stent in Liver Cirrhoses, sponsored by Institute of Liver and Biliary Sciences, India. Status unknown at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Trans Intrahepatic Portosystemic Shunt · Drug: Vasoactive Agent
Procedure: Self Expanding Metallic Stent · Drug: Vasoactive Agent
* 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.
* 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.
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
Plan to share: Undecided
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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Institute of Liver and Biliary Sciences, India