Minimally-Invasive Isolated Limb Perfusion (MI-ILP)

Vastra Gotaland Region

Status: Enrolling

Conditions: Isolated Limb Perfusion

Treatments: Other: Minimal-invasive isolated limb perfusion

Study type: Observational

Funder types: Other

Identifiers

NCT03376126

MI-ILP

Details and patient eligibility

About

The aim is to analyse feasibility of a minimally-invasive isolated limb perfusion.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

MI-ILP

Treatment:

Other: Minimal-invasive isolated limb perfusion