Fiber-Optic Navigation During TIPS Creation: A Prospective Pilot Study
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: Fiber-Optic Navigation System.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis, Refractory Ascites, Variceal Bleeding, 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
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fiber-Optic Navigation During Transjugular Intrahepatic Portosystemic Shunt Creation: A Prospective Pilot Study Evaluating Procedural Parameters
Overview
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.
Detailed description
Transjugular intrahepatic portosystemic shunt (TIPS) creation is an established minimally invasive treatment for complications of portal hypertension, including refractory ascites and variceal bleeding. The most technically demanding step of the procedure is the puncture of the portal vein from the hepatic vein through the liver parenchyma. This step is traditionally performed under fluoroscopic guidance and may require multiple puncture attempts, potentially leading to prolonged procedure times and increased radiation exposure.
Recent technological developments allow real-time three-dimensional visualization of guidewires and catheters using fiber-optic shape sensing technology. This approach may improve spatial orientation during complex endovascular procedures and facilitate more precise navigation within vascular structures.
The present prospective single-center pilot study aims to evaluate the feasibility and procedural impact of fiber-optic navigation during TIPS creation in routine clinical practice. Approximately 30 patients with an established clinical indication for TIPS placement will be included. Procedural parameters including number of puncture attempts, fluoroscopy time, radiation exposure (dose area product), total procedure time, technical success, and procedure-related complications will be prospectively recorded.
The results of this study are expected to provide initial clinical data on the integration of fiber-optic navigation into TIPS procedures and its potential impact on procedural efficiency and radiation safety.
Interventions
- Device Fiber-Optic Navigation System
Use 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.
Primary outcome measures
- Number of puncture attempts required to access the portal vein [Time frame: During the TIPS procedure]
Secondary outcome measures (5)
- Fluoroscopy Time [Time frame: During the procedure]
- Radiation Exposure [Time frame: During the procedure]
- Total Procedure Time [Time frame: During the procedure]
- Technical Success [Time frame: End of procedure]
- Procedure-Related Complications [Time frame: Within 30 days after the procedure]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
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
- Other
Study locations
Austria · 1 center
- Medical University of Innsbruck — Innsbruck
Identifiers
NCT: NCT07470515 · FLIGHT-2026