Fiber-Optic Navigation During TIPS Creation: A Prospective Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University Innsbruck
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Fiber-Optic Navigation System
DeviceUse of a fiber-optic shape sensing navigation system to assist catheter and guidewire navigation during transjugular intrahepatic portosystemic shunt (TIPS) creation. The system provides real-time three-dimensional visualization of endovascular devices and is used to support portal vein access during the procedure performed according to routine clinical practice.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Fiber-Optic Navigation-Assisted TIPSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of puncture attempts required to access the portal vein
Number of needle passes required to successfully puncture the portal vein during TIPS creation.
Time frame
During the TIPS procedureSecondary outcomes
1
Fluoroscopy Time
Total fluoroscopy time recorded during the TIPS procedure.
Time frame
During the procedure2
Radiation Exposure
Radiation exposure measured as dose area product (DAP) during the procedure.
Time frame
During the procedure3
Total Procedure Time
Total duration of the TIPS procedure measured from vascular access to completion of the intervention.
Time frame
During the procedure4
Technical Success
Successful placement of a transjugular intrahepatic portosystemic shunt with confirmed portal-systemic flow.
Time frame
End of procedureSponsors and contacts
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Source ClinicalTrials.gov
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