The Precise Selection of Stent Diameter for Portal Hypertension Patients With TIPS (NCT04421118) | Clinical Trial Compass
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The Precise Selection of Stent Diameter for Portal Hypertension Patients With TIPS
China60 participantsStarted 2021-06-11
Plain-language summary
The precise planning of TIPS, especially individual selection of stent diameter, is a hot and difficult topic in the field. We have successfully developed a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient based on three-dimensional modeling and fluid dynamics simulation. We propose the concept of virtual stent-based portal pressure gradient for the first time. With invasive pressure as reference, the accuracy of virtual stent-based portal pressure gradient will be evaluated in levels of animal experiments and clinical trials. The predictive value of virtual stent-based portal pressure gradient for individualized selection of TIPS stent diameter will be further assessed.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Criteria: Inclusion Criteria:
* age 18-75 years;
* high-risk treatment failure (e.g.Child-Pugh C or B grade with variceal bleeding);
* conventional drugs and endoscopic treatment of esophageal variceal bleeding are not good;
* End-stage liver disease with variceal bleeding before liver transplantation;
* successful implementation of TIPS;
* good compliance with the requirements formulated by the study;
* with written informed consent.
Exclusion Criteria:
* Liver transplantation in the past or planning liver transplantation in the 6 months;
* Common TIPS contraindications (e.g.NYHA level 2 of congestive heart failure ,history of pulmonary hypertension, portal vein trunk thrombosis, multiple liver cysts,or intrahepatic bile duct dilatation);
* severe liver dysfunction: prothrombin activity \<40% or bilirubin\> 50μmol / L or Child-Pugh score\> 12;
* history of hepatic encephalopathy;
* serum creatinine\> 133μmol / L;
* severe hyponatremia (blood sodium \<125mmol / L);
* uncontrollable infections;
* allergic to intravenous contrast agent;
* subject refused to participate in the trial or without the ability to participate in informed consent;
* previous history of TIPS treatment;
* any comorbidities or conditions that affect the test results as judged by the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of vsPPG
Timeframe: 1 day
Trial details
NCT IDNCT04421118
SponsorFirst Affiliated Hospital of Zhejiang University