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

NCT07470515 | Not Yet Recruiting

• 1 other identifier: FLIGHT-2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis; Refractory Ascites; Variceal Bleeding; Portal Hypertension

Keywords

TIPS; Portal Hypertension; Interventional Radiology; Fiber-Optic Navigation; Image-Guided Intervention; Endovascular Navigation; Radiation Reduction

Outcome Measures

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.

  During the TIPS procedure

Secondary Outcomes (5)

• Fluoroscopy Time

  During the procedure

• Radiation Exposure

  During the procedure

• Total Procedure Time

  During the procedure

• Technical Success

  End of procedure

• Procedure-Related Complications

  Within 30 days after the procedure

Study Arms (1)

Fiber-Optic Navigation-Assisted TIPS

EXPERIMENTAL

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

Interventions

Fiber-Optic Navigation System DEVICE

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.

Fiber-Optic Navigation-Assisted TIPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Liver Cirrhosis; Ascites; Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Malik Galijasevic, MD, PhD

CONTACT

+4351250483248; malik.galijasevic@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective single-center pilot study evaluating fiber-optic navigation during transjugular intrahepatic portosystemic shunt (TIPS) creation. All enrolled patients undergo TIPS placement according to routine clinical practice. Procedural parameters including number of puncture attempts, fluoroscopy time, radiation exposure, total procedure time, technical success, and complications are prospectively recorded and analyzed.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

AU (1)