Isolated Limb Perfusion
Conditions
Keywords
isolated limb perfusion
Brief summary
The aim is to analyse feasibility of a minimally-invasive isolated limb perfusion.
Detailed description
Isolated limb perfusion (ILP) and isolated limb infusion (ILI) are treatment options for patients with in-transit metastases of melanoma and locally advanced extremity sarcomas. There are several advantages for each method, but if the well-established effects of ILP could be combined to the minimally invasive approach of ILI, the results could be maximized and adverse events, related to open approach, minimized. A new method for vascular approach (MI-ILP) will be evaluated in a phase I feasibility study. Percutaneous vascular access of the ipsilateral side will be performed by ultrasound guided technique and connected to an extracorporeal oxygenation system. Perfusion will be conducted in the same way as for open ILP. Outcomes, technical details and complications will be recorded prospectively.
Interventions
OTHERMinimal-invasive isolated limb perfusion
Minimal-invasive isolated limb perfusion
Sponsors
Vastra Gotaland Region
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient scheduled for treatment with isolated hyperthermic perfusion 2. Age over 18 years. 3. Signed informed consent
Exclusion criteria
1. Re-perfusion 2. Lymph node metastases 3. Severe atherosclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion to open surgery | 1 day | Number of minimal-invasive procedure that will be converted to open surgery (per cent) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response | 3 months | Clinical response rate according to WHO criteria. |
| Complications | 30 days | Complications according to Clavien-Dindo |
Countries
Sweden
Outcome results
None listed