Clinical Efficacy and Survival Prediction Analysis of Transjugular Intrahepatic Portosystemic Shu… (NCT07437638) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Efficacy and Survival Prediction Analysis of Transjugular Intrahepatic Portosystemic Shunt in Patients With Liver Cirrhosis
China624 participantsStarted 2024-09-01
Plain-language summary
This study aims to develop a practical tool for identifying cirrhotic patients at high risk of hepatic encephalopathy following transjugular intrahepatic portosystemic shunt (TIPS) placement. A retrospective analysis will be conducted on medical records of 624 cirrhotic patients who underwent TIPS from 2011 to 2021. Statistical methods will be applied to screen preoperative routine indicators associated with post-TIPS hepatic encephalopathy risk. A predictive nomogram will be constructed incorporating the screened indicators to estimate individual preoperative risk. The predictive performance will be compared with conventional clinical scoring systems. This tool is intended to facilitate preoperative risk evaluation and targeted management of high-risk patients undergoing TIPS
Who can participate
Age range
18 Years – 80 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.
Inclusion Criteria:
* Age 18-80 years, regardless of gender
* Diagnosis of decompensated cirrhosis meeting clinical guidelines
* Complete preoperative baseline data available, with regular postoperative follow-up for at least 3 months to assess endpoint events
* Absence of absolute contraindications for TIPS
Exclusion Criteria:
* Age \< 18 or \> 80 years
* Non-cirrhotic portal hypertension
* Hepatocellular carcinoma or other systemic malignancies
* Severe cardiopulmonary disease
* Prior liver transplantation or portosystemic shunt surgery
* Death or liver transplantation within 30 days post-TIPS
* Missing key baseline data or loss to follow-up
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
Occurrence of hepatic encephalopathy within 3 months after TIPS
Timeframe: 3-month follow-up after TIPS
Trial details
NCT IDNCT07437638
SponsorThe Second Affiliated Hospital of Chongqing Medical University