Fiber-Optic Navigation During TIPS Creation: A Prospective Pilot Study

Starting soon · Not applicable

Conditions studied: Liver Cirrhosis, Refractory Ascites, Variceal Bleeding, Portal Hypertension

In brief

Transjugular intrahepatic portosystemic shunt (TIPS) creation is an established minimally invasive treatment for complications of portal hypertension such as refractory ascites and variceal bleeding. A technically challenging step of the procedure is the puncture of the portal vein from the hepatic vein, which is usually performed under fluoroscopic guidance and may require multiple puncture attempts. This prospective pilot study evaluates the use of fiber-optic navigation technology during TIPS creation. The system allows real-time three-dimensional visualization of guidewires and catheters and may improve spatial orientation during the procedure. Approximately 30 patients with a clinical indication for TIPS placement will be included. The study will assess procedural parameters such as the number of puncture attempts, fluoroscopy time, radiation exposure, procedure duration, technical success, and complications. The results may help to improve procedural efficiency and radiation safety during TIPS interventions.

Key facts

Study ID

NCT07470515

Run by

Medical University Innsbruck

People needed

30

Starts

2027-01-01

Expected to finish

2028-12-01

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Clinical indication for transjugular intrahepatic portosystemic shunt (TIPS) creation according to standard clinical practice (e.g., refractory ascites or variceal bleeding)
• Ability to provide written informed consent

You may not qualify if…

• Inability or unwillingness to provide informed consent
• Pregnancy or breastfeeding
• Absolute contraindications to TIPS according to current clinical standards (e.g., severe right heart failure, uncontrolled systemic infection)
• Participation in another clinical study that may interfere with the results of this study

Where it is running

• Medical University of Innsbruck — Innsbruck, Tyrol, Austria

Full record on ClinicalTrials.gov

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