Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06837974 | NOT YET RECRUITING | Portal Hypertension Related to Cirrhosis

AI-guided TIPS Procedure
Sponsor:

Wuhan Union Hospital, China

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

Condition or disease

Portal Hypertension Related to Cirrhosis

Intervention/treatment

AI guided TIPS

Artificially blinded TIPS

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Construction and Application of an AI Model for Guided TIPS Surgical Puncture: a Prospective Multicenter Randomized Controlled Trial
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2026-07-31
Estimated Study Completion Date : 2026-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
AI-guided TIPS Procedure

Location Details

NCT06837974

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Hubei

Wuhan Union Hospital

Wuhan, Hubei, China, 430022

Not yet recruiting

China, Hubei

Wuhan union jinyinhus hospital

Wuhan, Hubei, China, 430022

Not yet recruiting

China, Hubei

Wuhan Union West Hospital

Wuhan, Hubei, China, 430022