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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03363412 |
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Date of registration:
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29/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tips Underdilatation in Patients With Cirrhosis
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Scientific title:
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Covered Tips Under-dilatation to Less Than 8 mm: Feasibility and Clinical Efficacy. |
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Date of first enrolment:
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June 1, 2010 |
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Target sample size:
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148 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03363412 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Filippo Schepis, MD |
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Address:
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Telephone:
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+39 059 422 |
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Email:
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fschepis@unimore.it |
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Affiliation:
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Name:
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Filippo Schepis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Modena and Reggio Emilia |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cirrhosis
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Intervention(s)
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Device: PTFE-covered stent grafts
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Primary Outcome(s)
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The degree of stentgraft dilation
[Time Frame: 1 year]
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The incidence of at least one episode of PSE
[Time Frame: 1 year]
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Secondary Outcome(s)
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The absolute reduction of porto-systemic pressure gradient attained after TIPS placement;
[Time Frame: 1 year]
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The incidence of recurrent variceal bleeding and/or recurrent ascites
[Time Frame: 1 year]
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The incidence of shunt dysfunction requiring TIPS revision
[Time Frame: 1 year]
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Secondary ID(s)
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TIPS/10/17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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