Electromagnetic Positioning-Assisted Ultrasound Guidance in Transjugular Intrahepatic Portosystemic Shunt (TIPS)

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.

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Key information

Conditions

Portal Hypertension Digestive System Diseases Hypertension, Portal Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ultrasound combined with electromagnetic positioning guidance

Other

TIPS procedure under ultrasound combined with electromagnetic positioning guidance

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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaofeng Zhang

CONTACT

[email protected]

+8618565552050

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

Electromagnetic Positioning-Assisted Ultrasound Guidance in Transjugular Intrahepatic Portosystemic Shunt (TIPS): A Prospective, Single-Arm Study

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: May 20, 2025
Registry last updated: May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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