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.

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhoses
• Intervention / Treatment: Procedure: Trans Intrahepatic Portosystemic Shunt; Drug: Vasoactive Agent; Procedure: Self Expanding Metallic Stent

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver & Biliary Sciences
      • Contact: Dr Shushrut Singh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIPS + Vasoactive Drug	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.; Drug: Vasoactive Agent; Vasoactive Agent
Active Comparator: SEMS + Vasoactive Drug	Drug: Vasoactive Agent; Vasoactive Agent; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival in both groups	6 weeks

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-Cirrhosis-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No