AI-guided TIPS Procedure

Huazhong University of Science and Technology

Status: Not yet enrolling

Conditions: Portal Hypertension Related to Cirrhosis

Treatments: Other: AI guided TIPS; Other: Artificially blinded TIPS

Study type: Interventional

Funder types: Other

Identifiers

NCT06837974

GPS-TIPS001

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups, including a placebo group

AI guided TIPS

Experimental group

Description:

TIPS procedure will be conducted under the guidance of AI model

Treatment:

Other: AI guided TIPS

Artificially blinded TIPS

Placebo Comparator group

Description:

TIPS will be conducted based on the experience of operators.

Treatment:

Other: Artificially blinded TIPS