Minimally-Invasive Isolated Limb Perfusion (MI-ILP)
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|ClinicalTrials.gov Identifier: NCT03376126|
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment|
|Isolated Limb Perfusion||Other: Minimal-invasive isolated limb perfusion|
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|
|Estimated Enrollment :||10 participants|
|Official Title:||Minimally-Invasive Isolated Limb Perfusion|
|Actual Study Start Date :||June 1, 2016|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Other: Minimal-invasive isolated limb perfusion
Minimal-invasive isolated limb perfusion
- Conversion to open surgery [ Time Frame: 1 day ]Number of minimal-invasive procedure that will be converted to open surgery (per cent)
- Response [ Time Frame: 3 months ]Clinical response rate according to WHO criteria.
- Complications [ Time Frame: 30 days ]Complications according to Clavien-Dindo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376126
|Contact: Roger Olofsson Bagge, MD, PhD||+46 31 firstname.lastname@example.org|
|Sahlgrenska University Hospital||Recruiting|
|Gothenburg, Sweden, 413 45|
|Contact: Roger Olofsson Bagge, MD, PhD +46 31 3428207 email@example.com|
|Principal Investigator: Roger Olofsson Bagge, MD, PhD|