Viatorr CX Case-control Study for Complications of Portal Hypertension (VIATORR-CX)
April 23, 2019 updated by: Jonel Trebicka, University Hospital, Bonn
Viatorr Control Expansion Compared to Bare-metal and Regular Viatorr for Complications of Portal Hypertension
To evaluate the clinical benefits in the patients receiving Viatorr CX over a period of 12 months of structured Follow-up (before TIPS, at TIPS, 1 week after TIPS, at 6 weeks, 4 months, 6 months, 9 months, 12 months), regarding clinical endpoints, such as HE, readmission, liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Case-control study using the patients in the University Clinic Bonn receiving Viatorr CX (n=40), using a comparison ration 1:1:1 to Viatorr and bare metal stents.
Of these patients, 20 patients will receive Viatorr CX and the assessement of the width of the stent as outlined in the JVIR-paper published this year.
The Viatorr and BMS controls with similar age, gender, Child, MELD and indication for TIPS.
A total of 125 patients with the primary composite-endpoint HE/readmission will be investigated Secondary endpoints are liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bonn, Germany, 53127
- Laboratory for Liver Fibrosis and Portal Hypertension
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Case-control study using the patients in our center receiving Viatorr CX (n=40), using a comparison ration 1:1:1 to Viatorr and bare metal stents (all available data from our center).
Thereby, we will choose 20 patients receiving Viatorr CX and the assessement of the width of the stent as outlined in the JVIR-paper published this year.
The Viatorr and BMS controls with similar age, gender, Child, MELD and indication for TIPS.
We will investigate a total 125 patients with the primary composite-endpoint HE/readmission, and secondary endpoints will be liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.
Description
Inclusion Criteria:
- Patients suitable for TIPS
Exclusion Criteria:
- Contraindication for TIPS
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Bare metal stent (BMS) TIPS
retrospective patients receiving BMS-TIPS for treatment of complications of portal hypertension.
|
Transjugular Intrahepatic Portosystemic Shunt
|
|
Regular Viatorr (RV) TIPS
retrospective patients receiving RV-TIPS for treatment of complications of portal hypertension.
|
Transjugular Intrahepatic Portosystemic Shunt
|
|
Viatorr Control Expansion (VCX)TIPS
prospective patients receiving VCX-TIPS for treatment of complications of portal hypertension.
|
Transjugular Intrahepatic Portosystemic Shunt
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Readmissions
Time Frame: 12 months
|
Number of readmissions will be documented using a structured CRF
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hepatic encephalopathy (HE)
Time Frame: 12 months
|
Number of Episodes of overt HE (West Haven Criteria > Grad I)
|
12 months
|
|
Liver injury
Time Frame: 12 months
|
Increase in liver function tests
|
12 months
|
|
Response to TIPS
Time Frame: 12 months
|
grade of ascites after TIPS
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonel Trebicka, MD, PhD, Laboratory for Liver Fibrosis and Portal Hypertension
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
March 3, 2017
First Submitted That Met QC Criteria
March 13, 2017
First Posted (Actual)
March 20, 2017
Study Record Updates
Last Update Posted (Actual)
April 24, 2019
Last Update Submitted That Met QC Criteria
April 23, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIPS-CX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.