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.

NCT03827681 | Unknown

• 1 other identifier: ILBS-Cirrhosis-20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Survival in both groups

  6 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

TIPS + Vasoactive Drug

EXPERIMENTAL

Procedure: Trans Intrahepatic Portosystemic Shunt; Drug: Vasoactive Agent

SEMS + Vasoactive Drug

ACTIVE COMPARATOR

Procedure: Self Expanding Metallic Stent; Drug: Vasoactive Agent

Interventions

Trans Intrahepatic Portosystemic Shunt PROCEDURE

* 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.

TIPS + Vasoactive Drug

Self Expanding Metallic Stent PROCEDURE

* 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.

SEMS + Vasoactive Drug

Vasoactive Agent DRUG

Vasoactive Agent

SEMS + Vasoactive Drug; TIPS + Vasoactive Drug

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

Related Publications (1)

• Singh S, Arora V, Maiwall R, Mukund A, Jindal A, Choudhry A, Kumar G, Sarin SK. TIPS Is Superior to SEMS in the Management of Refractory VARICEAL Bleed in Advanced Cirrhosis Patients (TIPSEMS-VB Trial). Liver Int. 2025 Aug;45(8):e70178. doi: 10.1111/liv.70178.

  PMID: 40631454 DERIVED

MeSH Terms

Interventions

Vasoconstrictor Agents

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Dr Shushrut Singh, MD

CONTACT

01146300000; drsushrut20@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 1, 2019
• Study Start: February 6, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

IN (1)