AI-guided TIPS Procedure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
About this 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?
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
Eligibility criteria
Qualifiers
Participants who require transjugular intrahepatic portosystemic shunt (TIPS) and meet the clinical indications for the procedure.
Participants whose physical condition is suitable for TIPS.
Disqualifiers
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 design
Treatments tested in this trial
- AI guided TIPS
- Artificially blinded TIPS
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov