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

March 10, 2026 updated by: Medical University Innsbruck

Fiber-Optic Navigation During Transjugular Intrahepatic Portosystemic Shunt Creation: A Prospective Pilot Study Evaluating Procedural Parameters

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University of Innsbruck
        • Contact:
        • Principal Investigator:
          • Alexander Loizides, MD, Prof.
        • Sub-Investigator:
          • Malik Galijasevic, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fiber-Optic Navigation-Assisted TIPS
Patients undergo transjugular intrahepatic portosystemic shunt (TIPS) creation using fiber-optic navigation technology to assist catheter and guidewire navigation. The procedure is performed according to routine clinical practice at a tertiary interventional radiology center. Procedural parameters including number of puncture attempts, fluoroscopy time, radiation exposure, total procedure time, technical success, and procedure-related complications are prospectively recorded.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of puncture attempts required to access the portal vein
Time Frame: During the TIPS procedure
Number of needle passes required to successfully puncture the portal vein during TIPS creation.
During the TIPS procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoroscopy Time
Time Frame: During the procedure
Total fluoroscopy time recorded during the TIPS procedure.
During the procedure
Radiation Exposure
Time Frame: During the procedure
Radiation exposure measured as dose area product (DAP) during the procedure.
During the procedure
Total Procedure Time
Time Frame: During the procedure
Total duration of the TIPS procedure measured from vascular access to completion of the intervention.
During the procedure
Technical Success
Time Frame: End of procedure
Successful placement of a transjugular intrahepatic portosystemic shunt with confirmed portal-systemic flow.
End of procedure
Procedure-Related Complications
Time Frame: Within 30 days after the procedure
Occurrence of intra-procedural or early post-procedural complications.
Within 30 days after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLIGHT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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