NCT07909850Not yet recruiting
Development and Validation of a TIPS Prognostic Model
Development and Validation of a Prognostic Model for Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This multicenter, prospective observational study aims to learn whether a prediction model using routine clinical data, imaging findings (including spleen stiffness measurement), and circulating biomarkers can predict stent dysfunction and longer-term outcomes after transjugular intrahepatic portosystemic shunt (TIPS) in adults with portal hypertension. The main question it aims to answer is: Does this model predict TIPS stent dysfunction within 1 year after the procedure, and does it perform better than Doppler ultrasound for assessing stent function? Secondary questions include whether the model can predict further decompensation, liver failure, recompensation, and liver-related death over 3 years, and whether periodontal status and circulating biomarkers are associated with adverse outcomes after TIPS. About 1,490 participants aged 18-80 years who are scheduled to undergo TIPS as part of their routine medical care will be enrolled at multiple centers and followed for up to 3 years. This is an observational study; participants receive usual medical care, and no treatment is assigned by the study. No additional study-specific visits are required. Data will be collected from routine clinical records at baseline, during TIPS, within 1 week after TIPS, and at follow-up visits (1, 3, and 6 months, then every 6 months). Optional blood, stool, urine, gingival crevicular fluid, and subgingival plaque samples may be collected for biomarker and mechanism research. The primary endpoint is TIPS stent dysfunction within 1 year after the procedure.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1490 (estimated)
- First submitted
- 27 Oct 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Diseases
- High blood pressure
- NCT number
- NCT07909850
What you commit to
- Study type: Observational
- Planned participants: 1490
- From 1 Dec 2026 to the primary completion date, 1 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant intrahepatic or extrahepatic malignancy, including solid tumors and hematologic malignancies, or any other disease with expected survival \<6 months.
Other illness
- TIPS procedure failure.
Other
- Pregnant or breastfeeding women.
- Judged by the investigator as unsuitable to participate in this study.
Who the study is looking for
- Voluntary written informed consent provided by the participant.
- Age ≥18 years and ≤80 years; male or female.
- Scheduled to undergo transjugular intrahepatic portosystemic shunt (TIPS) per physician order as part of routine clinical care.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.