AI-guided TIPS Procedure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI guided TIPS, Artificially blinded TIPS.
- Who it may be relevant to
- Registry conditions: Portal Hypertension Related to Cirrhosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Construction and Application of an AI Model for Guided TIPS Surgical Puncture: a Prospective Multicenter Randomized Controlled Trial
Overview
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
Interventions
- Other AI guided TIPS
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. - Other Artificially blinded TIPS
The TIPS procedure will be conducted based on the experience of operators.
Primary outcome measures
- Number of punctures [Time frame: From the beginning to the end of the TIPS procedure.]
Secondary outcome measures (3)
- 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.]
Eligibility criteria
Inclusion criteria
- Participants who require transjugular intrahepatic portosystemic shunt (TIPS) and meet the clinical indications for the procedure.
- Participants whose physical condition is suitable for TIPS.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Wuhan Union Hospital — Wuhan
- Wuhan Union Jinyinhu Hospital — Wuhan
- Wuhan Union West Hospital — Wuhan
Identifiers
NCT: NCT06837974 · GPS-TIPS001