Portal Hypertension Related to CirrhosisNCT06837974
AI-guided TIPS Procedure
A study testing AI guided TIPS and Artificially blinded TIPS in people with Portal Hypertension Related to Cirrhosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites in China.
Trial summary
The goal of this clinical trial is to learn if transjugular intrahepatic portosystemic shunt (TIPS)-guided AI model can guide TIPS procedure in adults better than conventional TIPS procedure (artificially blinded TIPS). TIPS surgical outcomes and intraoperative and postoperative complications will also be observed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Portal Hypertension Related to Cirrhosis
- What is being tested?
- AI guided TIPS and Artificially blinded TIPS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2025to 31 Oct 2026
- Phase
- Interventional
- 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
Who may be able to join
- Participants who require transjugular intrahepatic portosystemic shunt (TIPS) and meet the clinical indications for the procedure.
- Participants whose physical condition is suitable for TIPS.
Who cannot join
- Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
- Participants are pregnant or breastfeeding.
- Participants are unwilling or unable to sign informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Wuhan Union Hospital
Wuhan, Hubei, 430022
Chuansheng Zheng, 13329702158, hqzcsxh@sina.com
Wuhan Union Jinyinhu Hospital
Wuhan, Hubei, 430022
Huangxuan Zhao, PhD, 18971676985, zhao_huangxuan@sina.com
Wuhan Union West Hospital
Wuhan, Hubei, 430022
About this study
Official title: Construction and Application of an AI Model for Guided TIPS Surgical Puncture: a Prospective Multicenter Randomized Controlled Trial
The goal of this clinical trial is to learn if transjugular intrahepatic portosystemic shunt (TIPS)-guided AI model can guide TIPS procedure in adults better than conventional TIPS procedure (artificially blinded TIPS). TIPS surgical outcomes and intraoperative and postoperative complications will also be observed. The main questions it aims to answer are:
- Does the AI model lower the number of punctures, radiation dose, and complications of participants undergo TIPS?
- Does the AI model improve the efficacy of TIPS for participants?
Read more
Participants will:
- Take the TIPS by the guidance of the AI model or conventional manually blinded penetration (placebo)
- The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications within 3 months will be recorded
- Intraoperative portal pressure gradient drop values, symptoms of ascites and rebleeding within 3 months after TIPS will be reported
- Conditions
- Portal Hypertension Related to Cirrhosis
- Being tested
- AI guided TIPS, Artificially blinded TIPS
- Keywords
- TIPS, AI, Efficacy, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI guided TIPSOther
The TIPS procedure will be conducted under the guidance of AI model which was constructed based on the pre-operation enhanced CT images and intra-operation DSA images.
Artificially blinded TIPSOther
The TIPS procedure will be conducted based on the experience of operators.
| Study group | Role | What they receive |
|---|---|---|
| AI guided TIPS | Experimental | TIPS procedure will be conducted under the guidance of AI model Receives: Other: AI guided TIPS |
| Artificially blinded TIPS | Placebo comparator | TIPS will be conducted based on the experience of operators. Receives: Other: Artificially blinded TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of punctures
The number of punctures is defined as the number of punctures to the liver during the establishment of the puncture channel during the TIPS procedure.
Measured: From the beginning to the end of the TIPS procedure.
Secondary outcomes (3)
Radiation dose
Radiation dose from the TIPS procedure.
Measured: From the beginning to the end of the TIPS procedure.
Surgical success rate
Procedural success was defined as the success of placing a stent and reducing the portal pressure gradient during the TIPS procedure
Measured: From the beginning to the end of the TIPS procedure.
Complications
Complications are defined as bleeding, infection, and other complications due to puncture.
Measured: From enrollment to the end of the TIPS procedure at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Hypertension Related to CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837974
- Sponsor's protocol ID
- GPS-TIPS001
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of an AI Model for Guided TIPS Surgical Puncture: a Prospective Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06837974
- Acronym / sponsor ID
- GPS-TIPS001
- Conditions
- Portal Hypertension Related to Cirrhosis
- Keywords
- TIPS, AI, Efficacy, Complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if transjugular intrahepatic portosystemic shunt (TIPS)-guided AI model can guide TIPS procedure in adults better than conventional TIPS procedure (artificially blinded TIPS). TIPS surgical outcomes and intraoperative and postoperative complications will also be observed. The main questions it aims to answer are:
- Does the AI model lower the number of punctures, radiation dose, and complications of participants undergo TIPS?
- Does the AI model improve the efficacy of TIPS for participants?
Participants will:
- Take the TIPS by the guidance of the AI model or conventional manually blinded penetration (placebo)
- The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications within 3 months will be recorded
- Intraoperative portal pressure gradient drop values, symptoms of ascites and rebleeding within 3 months after TIPS will be reported
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI guided TIPS | Experimental | Other: AI guided TIPSTIPS procedure will be conducted under the guidance of AI model |
| Artificially blinded TIPS | Placebo comparator | Other: Artificially blinded TIPSTIPS will be conducted based on the experience of operators. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants who require transjugular intrahepatic portosystemic shunt (TIPS) and meet the clinical indications for the procedure.
- Participants whose physical condition is suitable for TIPS.
Key exclusion criteria (3 listed)
- Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
- Participants are pregnant or breastfeeding.
- Participants are unwilling or unable to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI guided TIPSThe TIPS procedure will be conducted under the guidance of AI model which was constructed based on the pre-operation enhanced CT images and intra-operation DSA images. | Other | AI guided TIPS |
| Artificially blinded TIPSThe TIPS procedure will be conducted based on the experience of operators. | Other | Artificially blinded TIPS |
Primary outcome
Number of punctures
Time frame: From the beginning to the end of the TIPS procedure.
The number of punctures is defined as the number of punctures to the liver during the establishment of the puncture channel during the TIPS procedure.
3 secondary outcomes
Radiation dose
Time frame: From the beginning to the end of the TIPS procedure.
Surgical success rate
Time frame: From the beginning to the end of the TIPS procedure.
Complications
Time frame: From enrollment to the end of the TIPS procedure at 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI guided TIPS and Artificially blinded TIPS in people with Portal Hypertension Related to Cirrhosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites in China.
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 2 inclusion and 3 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Lei Chen (+8615971480677, chan0812@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of punctures (time frame: From the beginning to the end of the TIPS procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2025.