NCT06837974

AI-guided TIPS Procedure

Construction and Application of an AI Model for Guided TIPS Surgical Puncture: a Prospective Multicenter Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. 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

Conditions

• Portal Hypertension Related to Cirrhosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-31
• Completion: 2026-10-31
• First posted: 2025-02-20
• Last updated: 2025-02-20

Locations

3 sites across 1 country: China