Portal Hypertension Related to Cirrhosis
Conditions
Keywords
TIPS, AI, Efficacy, Complications
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
Interventions
OTHERAI 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.
OTHERArtificially blinded TIPS
The TIPS procedure will be conducted based on the experience of operators.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of punctures | 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
| Measure | Time frame | Description |
|---|---|---|
| Radiation dose | From the beginning to the end of the TIPS procedure. | Radiation dose from the TIPS procedure. |
| Surgical success rate | 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 |
| Complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Portal pressure gradient | 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. |
Countries
China
Contacts
Primary ContactLei Chen
Outcome results
None listed