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NCT Number: NCT06837974

AI-guided TIPS Procedure

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

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Key information

Conditions

Portal Hypertension Related to Cirrhosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Union Hospital, Wuhan, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI guided TIPS

Other

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.

Artificially blinded TIPS

Other

The TIPS procedure will be conducted based on the experience of operators.

Primary outcomes

  1. Number of punctures

    Time frame: From the beginning to the end of the TIPS procedure.

    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.

Secondary outcomes

  1. Radiation dose

    Time frame: From the beginning to the end of the TIPS procedure.

    Radiation dose from the TIPS procedure.

  2. Surgical success rate

    Time frame: From the beginning to the end of the TIPS procedure.

    Procedural success was defined as the success of placing a stent and reducing the portal pressure gradient during the TIPS procedure

  3. Complications

    Time frame: From enrollment to the end of the TIPS procedure at 3 months.

    Complications are defined as bleeding, infection, and other complications due to puncture.

Other outcomes

  1. Portal pressure gradient

    Time frame: From the beginning to the end of the TIPS procedure.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Chen

CONTACT

[email protected]

+8615971480677

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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