Minimally-Invasive Isolated Limb Perfusion (MI-ILP)

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

Study Overview

• Status: Recruiting
• Conditions: Isolated Limb Perfusion
• Intervention / Treatment: Other: Minimal-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 Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Roger Olofsson Bagge, MD, PhD; Phone Number: +46 31 3420000; Email: roger.olofsson.bagge@gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Roger Olofsson Bagge, MD, PhD; Phone Number: +46 31 3428207; Email: roger.olofsson@surgery.gu.se
    • Principal Investigator: Roger Olofsson Bagge, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for isolated limb perfusion.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MI-ILP	Other: Minimal-invasive isolated limb perfusion; Minimal-invasive isolated limb perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion to open surgery	Number of minimal-invasive procedure that will be converted to open surgery (per cent)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response	Clinical response rate according to WHO criteria.	3 months
Complications	Complications according to Clavien-Dindo	30 days

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: isolated limb perfusion
• Other Study ID Numbers: MI-ILP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No