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Not yet recruiting NCT06979622

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

No phase Interventional Portal Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ultrasound combined with electromagnetic positioning guidance.
Who it may be relevant to
Registry conditions: Portal Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other ultrasound combined with electromagnetic positioning guidance
    TIPS procedure under ultrasound combined with electromagnetic positioning guidance

Primary outcome measures

  • Success rate of portal vein puncture [Time frame: During TIPS procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06979622 · NFEC-2025-136

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗