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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AI guided TIPS
Other interventionThe 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 TIPS
Other interventionThe TIPS procedure will be conducted based on the experience of operators.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: AI guided TIPSExperimental treatment 1 intervention
Group B: Artificially blinded TIPSPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the beginning to the end of the TIPS procedure.Secondary outcomes
1
Radiation dose
Radiation dose from the TIPS procedure.
Time frame
From the beginning to the end of the TIPS procedure.2
Surgical success rate
Procedural success was defined as the success of placing a stent and reducing the portal pressure gradient during the TIPS procedure
Time frame
From the beginning to the end of the TIPS procedure.3
Complications
Complications are defined as bleeding, infection, and other complications due to puncture.
Time frame
From enrollment to the end of the TIPS procedure at 3 months.Other outcomes
1
Portal pressure gradient
The hepatic venous pressure gradient (HVPG) is an indirect method of assessing the portal pressure gradient by determining the difference between wedged hepatic venous pressure (WHVP) and free hepatic venous pressure (FHVP). pressure (FHVP), which reflects the pressure difference between the portal vein and the intra-abdominal vena cava.
Time frame
From the beginning to the end of the TIPS procedure.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: