Tips Underdilatation in Patients With Cirrhosis
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|ClinicalTrials.gov Identifier: NCT03363412|
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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.
- 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)
- 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.
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
|University of Florence|
|Principal Investigator:||Filippo Schepis, MD||University of Modena and Reggio Emilia|