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Tips Underdilatation in Patients With Cirrhosis

NCT03363412 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2020-11-27

No results posted yet for this study

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

Interventions

DEVICE

PTFE-covered stent grafts

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

Sponsors & Collaborators

  • University of Florence

    collaborator OTHER

  • University of Modena and Reggio Emilia

    lead OTHER

Principal Investigators

  • Filippo Schepis, MD · University of Modena and Reggio Emilia

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-01
Primary Completion
2021-06-30
Completion
2021-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03363412 on ClinicalTrials.gov