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.

Liver Cirrhoses Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827681
• Other study ID #: ILBS-Cirrhosis-20
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2020
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Shushrut Singh, MD
• Phone: 01146300000
• Email: drsushrut20[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cirrhoses
• Liver Cirrhosis

Intervention

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.
• 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

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival in both groups		6 weeks
Secondary	Re-bleeding in both groups for 5 days from end of therapy		5 days
Secondary	Rebleeding in both groups		6 weeks
Secondary	Decompensation in both groups in the form of ascites or Hepatic Encephalopathy		6 weeks
Secondary	Adverse events in both groups		6 weeks
Secondary	Worsening of liver severity score in both groups.		6 weeks