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

Medical University Innsbruck

Status: Begins enrollment in 8 months

Conditions: Portal Hypertension; Refractory Ascites; Variceal Bleeding; Liver Cirrhosis

Treatments: Device: Fiber-Optic Navigation System

Study type: Interventional

Funder types: Other

Identifiers

NCT07470515

FLIGHT-2026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Fiber-Optic Navigation-Assisted TIPS

Experimental group

Description:

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.

Treatment:

Device: Fiber-Optic Navigation System