AI-guided TIPS Procedure

February 16, 2025 updated by: Wuhan Union Hospital, China

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Jinyinhu Hospital
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Wuhan Union West Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI guided TIPS
TIPS procedure will be conducted under the guidance of AI model
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.
Placebo Comparator: Artificially blinded TIPS
TIPS will be conducted based on the experience of operators.
Other: Artificially blinded TIPS
The TIPS procedure will be conducted based on the experience of operators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the beginning to the end of the TIPS procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation dose
Time Frame: From the beginning to the end of the TIPS procedure.
Radiation dose from the TIPS procedure.
From the beginning to the end of the TIPS procedure.
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
From the beginning to the end of the TIPS procedure.
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.
From enrollment to the end of the TIPS procedure at 3 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the beginning to the end of the TIPS procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 16, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPS-TIPS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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