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Tips Underdilatation in Patients With Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363412
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
University of Florence
Information provided by (Responsible Party):
Filippo Schepis, University of Modena and Reggio Emilia

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.


Condition or disease Intervention/treatment Phase
Cirrhosis Device: PTFE-covered stent grafts Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Covered Tips Under-dilatation to Less Than 8 mm: Feasibility and Clinical Efficacy.
Actual Study Start Date : June 1, 2010
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : July 30, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: Underdilated TIPS
Patients will be treated with PTFE-covered stent grafts balloon-dilated to less than 8 mm.
Device: PTFE-covered stent grafts
Creation of a small diameter intrahepatic shunt between portal and hepatic veins.
Other Name: VIATORR




Primary Outcome Measures :
  1. The incidence of at least one episode of PSE [ Time Frame: 1 year ]
    West Haven grade II PSE or higher as evaluated by two observers at follow-up


Secondary Outcome Measures :
  1. The incidence of shunt dysfunction requiring TIPS revision [ Time Frame: 1 year ]
    Invasive TIPS revision will be performed in case of recurrent variceal hemorrhage, continued need for paracentesis and/or if Doppler ultrasonography shows changes in the direction of flow in intrahepatic portal branches. TIPS will be considered as dysfunctional if the porto-systemic pressure gradient will be above the value recorded after the shunt creation.

  2. The incidence of recurrent variceal bleeding and/or recurrent ascites [ Time Frame: 1 year ]
    Variceal bleeding defined following Baveno indications. Ascites defined as the need for at least one large-volume paracentesis by 4 weeks after TIPS placement)

  3. The absolute reduction of porto-systemic pressure gradient attained after TIPS placement; [ Time Frame: 1 year ]
    Values of post-TIPS porto-systemic pressure gradient will be classified as below 12 and 10 mmHg.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363412


Locations
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Italy
University of Florence
Florence, Italy
Filippo Schepis
Modena, Italy
Sponsors and Collaborators
University of Modena and Reggio Emilia
University of Florence
Investigators
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Principal Investigator: Filippo Schepis, MD University of Modena and Reggio Emilia
Publications:

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Responsible Party: Filippo Schepis, MD, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT03363412    
Other Study ID Numbers: TIPS/10/17
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases