Tips Underdilatation in Patients With Cirrhosis

NCT03363412 | Unknown

• 1 other identifier: TIPS/10/17
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

Brief Summary

The transjugular intrahepatic portosystemic shunt (TIPS) is a well-established procedure for the treatment of portal hypertensive bleeding, refractory ascites and vascular diseases of the liver. The major drawbacks of this procedure are shunt dysfunction and portosystemic encephalopathy (PSE). The availability of self-expandable polytetrafluoroethylene-covered stentgrafts (PTFE-SGs) has dramatically improved the long-term patency of TIPS. However, the incidence of PSE remains a threatening complication in about 50% of patients. The Investigators hypothesized that under-dilated PTFE-SGs would not self-expand to nominal diameter and their under-dilation would be safe and could reduce the rate of post-TIPS encephalopathy, while maintaining clinical efficacy. Aim of this proof-of-concept exploratory study is to determine whether "under-dilated TIPS" is a feasible procedure that reduces the incidence of PSE while maintaining clinical efficacy.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (2)

• The degree of stentgraft dilation

  Modification of pressure gradients inside the intraparenchimal tract of the TIPS and/or its diameter at CT scan

  1 year

• The incidence of at least one episode of PSE

  West Haven grade II PSE or higher as evaluated by two observers at follow-up

  1 year

Secondary Outcomes (3)

• The incidence of shunt dysfunction requiring TIPS revision

  1 year

• The incidence of recurrent variceal bleeding and/or recurrent ascites

  1 year

• The absolute reduction of porto-systemic pressure gradient attained after TIPS placement;

  1 year

Study Arms (1)

Underdilated TIPS

EXPERIMENTAL

Patients will be treated with PTFE-covered stent grafts balloon-dilated to less than 8 mm.

Device: PTFE-covered stent grafts

Interventions

PTFE-covered stent grafts DEVICE

Creation of a small diameter intrahepatic shunt between portal and hepatic veins.

Also known as: VIATORR, VIATORR CX

Underdilated TIPS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of cirrhosis determined on the basis of clinical history, histological examination, morphological characteristics of the liver at ultrasound, computed tomography or magnetic resonance imaging;
• TIPS placed to prevent recurrent variceal bleeding or to control refractory ascites, according to current guidelines.

You may not qualify if:

• placement of two or more coaxial stent grafts;
• refusal to consent to have TIPS dilated to a small diameter and/or to attend follow-up visits;
• TIPS placed in the setting of acute variceal hemorrhage either as "early" TIPS or as salvage TIPS for continued bleeding or early rebleeding.

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead
• University of Florence: collaborator

Study Sites (2)

University of Florence

Florence, Italy

RECRUITING

Filippo Schepis

Modena, Italy

RECRUITING

Related Publications (5)

• Boyer TD, Haskal ZJ; American Association for the Study of Liver Diseases. The Role of Transjugular Intrahepatic Portosystemic Shunt (TIPS) in the Management of Portal Hypertension: update 2009. Hepatology. 2010 Jan;51(1):306. doi: 10.1002/hep.23383. No abstract available.

  PMID: 19902484 BACKGROUND

• Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Peron JM, Abraldes JG, Bouchard L, Bilbao JI, Bosch J, Rousseau H, Vinel JP. Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study. Gastroenterology. 2004 Feb;126(2):469-75. doi: 10.1053/j.gastro.2003.11.016.

  PMID: 14762784 BACKGROUND

• Riggio O, Angeloni S, Salvatori FM, De Santis A, Cerini F, Farcomeni A, Attili AF, Merli M. Incidence, natural history, and risk factors of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt with polytetrafluoroethylene-covered stent grafts. Am J Gastroenterol. 2008 Nov;103(11):2738-46. doi: 10.1111/j.1572-0241.2008.02102.x. Epub 2008 Sep 4.

  PMID: 18775022 BACKGROUND

• Casado M, Bosch J, Garcia-Pagan JC, Bru C, Banares R, Bandi JC, Escorsell A, Rodriguez-Laiz JM, Gilabert R, Feu F, Schorlemer C, Echenagusia A, Rodes J. Clinical events after transjugular intrahepatic portosystemic shunt: correlation with hemodynamic findings. Gastroenterology. 1998 Jun;114(6):1296-303. doi: 10.1016/s0016-5085(98)70436-6.

  PMID: 9609767 BACKGROUND

• Riggio O, Ridola L, Angeloni S, Cerini F, Pasquale C, Attili AF, Fanelli F, Merli M, Salvatori FM. Clinical efficacy of transjugular intrahepatic portosystemic shunt created with covered stents with different diameters: results of a randomized controlled trial. J Hepatol. 2010 Aug;53(2):267-72. doi: 10.1016/j.jhep.2010.02.033. Epub 2010 Apr 27.

  PMID: 20537753 BACKGROUND

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Filippo Schepis, MD

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filippo Schepis, MD

CONTACT

+39 059 422; fschepis@unimore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 6, 2017
• Study Start: June 1, 2010
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2021
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)