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Portal Hypertension Related to CirrhosisC-SIPSNCT07909850

Development and Validation of a TIPS Prognostic Model

An observational study of Portal Hypertension Related to Cirrhosis and Ascites, run by The Second Affiliated Hospital of Chongqing Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
1,490 participants
Where
No sites listed yet
Study dates
1 Dec 2026to 1 Dec 2032
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consists of adults aged 18-80 years with portal hypertension who are scheduled to undergo transjugular intrahepatic portosystemic shunt (TIPS) as part of routine clinical care at multiple participating centers. Approximately 1,490 participants will be enrolled in this multicenter, prospective observational cohort. Patients with intrahepatic or extrahepatic malignancy (including solid and hematologic tumors), other diseases with expected survival <6 months, failed TIPS, pregnancy or breastfeeding, or those judged unsuitable by the investigator will be excluded. Participants receive usual medical care without study-assigned treatment and are followed for up to 3 years through routine clinical visits (1, 3, and 6 months after TIPS, then every 6 months) to capture stent dysfunction, further decompensation, recompensation, liver failure, and liver disease-related death.

Who may be able to join

  • 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.

Who cannot join

  • Concomitant intrahepatic or extrahepatic malignancy, including solid tumors and hematologic malignancies, or any other disease with expected survival <6 months.
  • TIPS procedure failure.
  • Pregnant or breastfeeding women.
  • Judged by the investigator as unsuitable to participate in this study.

About this study

Official title: Development and Validation of a Prognostic Model for Transjugular Intrahepatic Portosystemic Shunt (TIPS)

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.

Medical subject headings
Ascites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07909850
Study groupRoleWhat they receive
TIPS cohortNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TIPS stent dysfunction within 1 year after TIPS

    Incidence of TIPS stent dysfunction, defined as either: (1) no clinical response or recurrence of portal hypertension complications (ascites not relieved or new/worsening ascites; variceal rebleeding; new or unexplained hepatic hydrothorax); or (2) Doppler ultrasound evidence of TIPS stent dysfunction (e.g., significantly abnormal intra-stent flow velocity, decreased main portal vein velocity, or hepatofugal flow in intrahepatic portal branches). Either condition must be confirmed by subsequent angiography showing stent or outflow tract stenosis ≥50% or complete occlusion, or by a portal pressure gradient (PPG) >12 mmHg or a ≤50% reduction from the preprocedural baseline PPG.

    Measured: Within 1 year after the TIPS procedure (from the index TIPS procedure through 12 months).

Secondary outcomes (5)

  1. Further decompensation within 3 years after TIPS

    Incidence of further decompensation, defined per Baveno VII as any of the following: (1) a second portal hypertension-related decompensating event (ascites, variceal bleeding, or hepatic encephalopathy); (2) recurrent variceal bleeding, recurrent ascites (requiring ≥3 large-volume paracenteses within 1 year), recurrent encephalopathy, spontaneous bacterial peritonitis, and/or hepatorenal syndrome-related acute kidney injury; or (3) new-onset ascites or encephalopathy after TIPS in patients whose only pre-TIPS decompensation was variceal bleeding

    Measured: Within 3 years after the TIPS procedure.

  2. Recompensation within 3 years after TIPS

    Incidence of recompensation, defined per Baveno VII as sustained resolution of ascites, hepatic encephalopathy, and variceal bleeding for at least 12 months after removal/control of the underlying etiology, together with stable improvement in liver function.

    Measured: Within 3 years after the TIPS procedure.

  3. Liver failure within 1 year after TIPS

    Incidence of liver failure, defined per the EASL Clinical Practice Guidelines on acute-on-chronic liver failure (2023) as total bilirubin ≥12 mg/dL plus any of the following: (1) INR ≥2.5; (2) serum creatinine ≥2.0 mg/dL or need for renal replacement therapy; (3) hepatic encephalopathy grade ≥3 (West Haven); (4) need for vasopressors to maintain blood pressure; or (5) PaO2/FiO2 ≤200 or SpO2/FiO2 ≤214.

    Measured: Within 1 year after the TIPS procedure.

  4. Liver failure within 3 years after TIPS

    Incidence of liver failure, defined per the EASL Clinical Practice Guidelines on acute-on-chronic liver failure (2023) as total bilirubin ≥12 mg/dL plus any of the following: (1) INR ≥2.5; (2) serum creatinine ≥2.0 mg/dL or need for renal replacement therapy; (3) hepatic encephalopathy grade ≥3 (West Haven); (4) need for vasopressors to maintain blood pressure; or (5) PaO2/FiO2 ≤200 or SpO2/FiO2 ≤214.

    Measured: Within 3 years after the TIPS procedure.

  5. Liver disease-related death within 3 years after TIPS

    Incidence of death directly attributable to liver disease, including death from liver failure, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, or other liver-related causes, as recorded during routine follow-up.

    Measured: Within 3 years after the TIPS procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,490 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07909850
Sponsor's protocol ID
2026-IIT-SL-283
Acronym
C-SIPS
Status last verified
Oct 2026
First submitted
27 Oct 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Portal Hypertension Related to Cirrhosis and Ascites, run by The Second Affiliated Hospital of Chongqing Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TIPS stent dysfunction within 1 year after TIPS (time frame: Within 1 year after the TIPS procedure (from the index TIPS procedure through 12 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07909850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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