Liver Cirrhosis, Portal Hypertension, Refractory Ascites, Variceal Bleeding
Conditions
Keywords
TIPS, Portal Hypertension, Interventional Radiology, Fiber-Optic Navigation, Image-Guided Intervention, Endovascular Navigation, Radiation Reduction
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.
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
DEVICEFiber-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.
Sponsors
Medical University Innsbruck
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of puncture attempts required to access the portal vein | During the TIPS procedure | Number of needle passes required to successfully puncture the portal vein during TIPS creation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy Time | During the procedure | Total fluoroscopy time recorded during the TIPS procedure. |
| Radiation Exposure | During the procedure | Radiation exposure measured as dose area product (DAP) during the procedure. |
| Total Procedure Time | During the procedure | Total duration of the TIPS procedure measured from vascular access to completion of the intervention. |
| Technical Success | End of procedure | Successful placement of a transjugular intrahepatic portosystemic shunt with confirmed portal-systemic flow. |
| Procedure-Related Complications | Within 30 days after the procedure | Occurrence of intra-procedural or early post-procedural complications. |
Countries
Austria
Contacts
CONTACTMalik Galijasevic, MD, PhD
Outcome results
None listed