Minimally-Invasive Isolated Limb Perfusion

Recruiting

• Conditions: Isolated Limb Perfusion
• Interventions: Other: Minimal-invasive isolated limb perfusion

• Registration Number: NCT03376126
• Lead Sponsor: Vastra Gotaland Region

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.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-18
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MI-ILP	Minimal-invasive isolated limb perfusion	-

Primary Outcome Measures

Name	Time	Method
Conversion to open surgery	1 day	Number of minimal-invasive procedure that will be converted to open surgery (per cent)

Secondary Outcome Measures

Name	Time	Method
Response	3 months	Clinical response rate according to WHO criteria.
Complications	30 days	Complications according to Clavien-Dindo

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden