Electromagnetic Positioning-Assisted Ultrasound Guidance in Transjugular Intrahepatic Portosystemic Shunt (TIPS): A Prospective, Single-Arm Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 20
- Primary Endpoint
- Success rate of portal vein puncture
Study Overview
Brief Summary
Transjugular intrahepatic portosystemic shunt (TIPS) is an important method for treating complications related to portal hypertension. The difficulty of its surgical procedures lies in portal vein puncture. Improper operation may lead to complications such as hepatic artery hemorrhage, hepatic capsular hemorrhage, and biliary tract hemorrhage. At present, the means of guiding portal vein puncture are limited. There is evidence supporting that ultrasound guidance can help reduce the number of punctures and lower the radiation dose, etc. However, ordinary ultrasound is limited by the influence of dimensions and can only guide punctures in the same plane, with limited guiding value. The use of the Imedis9000 magnetic navigation system can guide percutaneous vascular puncture in multiple dimensions, which can increase the success rate of puncture and shorten the operation time. This study conducted a prospective, single-arm study. The Imedis9000 magnetic navigation system was used for real-time positioning to guide precise TIPS stent implantation. The number of punctures, puncture success rate, stent implantation success rate, and the incidence of adverse events were evaluated to determine the application value of the Imedis9000 magnetic navigation system in TIPS procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age≥18 years old;
- •Including but not limited to patients requiring TIPS for: acute esophageal/gastric variceal bleeding, portal hypertensive gastropathy, cirrhotic ascites, cirrhotic hydrothorax, hepatorenal syndrome, Budd-Chiari syndrome, atypical portal hypertension, portal vein thrombosis, prevention of recurrent esophageal/gastric variceal bleeding, or prevention of recurrent ectopic variceal bleeding;
- •Deemed by clinicians to require Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- •Voluntarily signed informed consent form
Exclusion Criteria
- •Severe right heart failure, congestive heart failure (ejection fraction <40%), or severe valvular heart disease;
- •Persistent severe pulmonary hypertension (mean pulmonary artery pressure >45 mmHg) despite treatment;
- •Uncontrolled systemic infection or inflammation;
- •Hepatic encephalopathy stage III-IV;
- •Presence of cardiac pacemaker, metallic implants, or other conditions susceptible to electromagnetic interference;
- •Pregnancy or lactation;
- •Poor visualization of the portal venous system on ultrasound;
- •Investigator-determined unsuitability for study participation.
Arms & Interventions
TIPS procedure under ultrasound combined with electromagnetic positioning guidance
Intervention: ultrasound combined with electromagnetic positioning guidance (Other)
Outcomes
Primary Outcomes
Success rate of portal vein puncture
Time Frame: During TIPS procedure
Puncture success rate = Number of successful cases/total number of cases ×100%.
Secondary Outcomes
No secondary outcomes reported