Liver Metastases
Conditions
Keywords
Liver Percutaneous Isolated Localized Perfusion, PILP, Isolated Hepatic Perfusion, IHP, Liver metastases, Unresectable liver metastases of different etiologies
Brief summary
The purpose of this study is to determine whether the PILP-kit can be safely used, within specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic drug for the treatment of patients with unresectable liver metastases.
Detailed description
The objective of this Medical Device Study, is to demonstrate the feasibility of the liver PILP intervention. The liver PILP intervention will be considered feasible if the procedure is demonstrated to be safe and the liver PILP kit performs according to specifications.
Interventions
DEVICELiver-PILP kit
Device: Liver-PILP kit The Liver-PILP kit (three devices) is composed of percutaneous, disposable (single-use), catheter-based devices for targeted, isolated, organ specific (liver), drug delivery and perfusion with high dose drugs. 1. The Portal Vein Device (PVD): balloon catheter to occlude the portal vein and allow aspiration through a central lumen for portal veno-venous bypass. 2. The Hepatic Artery Device (HAD): balloon catheter to occlude arterial flow to the liver. 3. The Vena Cava Device (VCD): catheter based device to isolate and access hepatic outflow to vena cava by creating a closed chamber in vena cava at ostia of the hepatic veins while maintaining central vena cava blood flow from lower extremities to right atrium through reduced central lumen.
Sponsors
Celerion
Cromsource
Medical Device Works NV SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects with ECOG (Eastern Cooperative Oncology Group) stages 0 or 1 2. Unresectable metastatic disease predominant in the liver
Exclusion criteria
1. More than 60 % tumor involved liver tissue 2. Abnormal vascular anatomy 3. Severe atherosclerosis 4. Dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries 5. Short suprahepatic vena cava segment (\< 1.5 cm) 6. One or both jugular veins are occluded 7. Other severe, concomitant diseases regarding the subject status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate the feasibility of the liver PILP intervention. | During intervention and up to 30 days post intervention | The liver PILP intervention will be considered feasible if the intervention is demonstrated to be safe and the PILP kit performs according to specifications related to localization, flow rates and retrieval of devices. |
Countries
Belgium
Contacts
Primary ContactEric Van Cutsem, Prof MD PhD
Outcome results
None listed