Minimally-Invasive Isolated Limb Perfusion

Isolated Limb Perfusion Clinical Trial

— MI-ILP  

Official title:

Minimally-Invasive Isolated Limb Perfusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03376126
• Other study ID #: MI-ILP
• Status: Recruiting
• Start date: June 1, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Vastra Gotaland Region
• Contact: Roger Olofsson Bagge, MD, PhD
• Phone: +46 31 3420000
• Email: roger.olofsson.bagge[@]gu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Isolated Limb Perfusion

Intervention

Other:
• Minimal-invasive isolated limb perfusion
Minimal-invasive isolated limb perfusion

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion to open surgery	Number of minimal-invasive procedure that will be converted to open surgery (per cent)	1 day
Secondary	Response	Clinical response rate according to WHO criteria.	3 months
Secondary	Complications	Complications according to Clavien-Dindo	30 days