NCT06837974

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jul 2025

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jul 2025Oct 2026

First Submitted

Initial submission to the registry

February 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

February 16, 2025

Last Update Submit

February 16, 2025

Conditions

Portal Hypertension Related to Cirrhosis

Keywords

TIPSAIEfficacyComplications

Outcome Measures

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.

    From the beginning to the end of the TIPS procedure.

Secondary Outcomes (3)

  • Radiation dose

    From the beginning to the end of the TIPS procedure.

  • Surgical success rate

    From the beginning to the end of the TIPS procedure.

  • Complications

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

Other Outcomes (1)

  • Portal pressure gradient

    From the beginning to the end of the TIPS procedure.

Study Arms (2)

AI guided TIPS

EXPERIMENTAL

TIPS procedure will be conducted under the guidance of AI model

Other: AI guided TIPS

Artificially blinded TIPS

PLACEBO COMPARATOR

TIPS will be conducted based on the experience of operators.

Other: Artificially blinded TIPS

Interventions

AI guided TIPSOTHER

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.

AI guided TIPS
Artificially blinded TIPSOTHER

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

Artificially blinded TIPS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who require transjugular intrahepatic portosystemic shunt (TIPS) and meet the clinical indications for the procedure.
  • Participants whose physical condition is suitable for TIPS.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Wuhan Union Jinyinhu Hospital

Wuhan, Hubei, 430022, China

Location

Wuhan Union West Hospital

Wuhan, Hubei, 430022, China

Location

Central Study Contacts

Lei Chen

CONTACT

+8615971480677chan0812@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2025

First Posted

February 20, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)