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Minimally-Invasive Isolated Limb Perfusion (MI-ILP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376126
Recruitment Status : Unknown
Verified December 2017 by Roger Olofsson Bagge, Sahlgrenska University Hospital, Sweden.
Recruitment status was:  Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Roger Olofsson Bagge, Sahlgrenska University Hospital, Sweden

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

Condition or disease Intervention/treatment
Isolated Limb Perfusion 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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minimally-Invasive Isolated Limb Perfusion
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

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




Primary Outcome Measures :
  1. Conversion to open surgery [ Time Frame: 1 day ]
    Number of minimal-invasive procedure that will be converted to open surgery (per cent)


Secondary Outcome Measures :
  1. Response [ Time Frame: 3 months ]
    Clinical response rate according to WHO criteria.

  2. Complications [ Time Frame: 30 days ]
    Complications according to Clavien-Dindo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for isolated limb perfusion.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Roger Olofsson Bagge, MD, PhD +46 31 3420000 roger.olofsson.bagge@gu.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 413 45
Contact: Roger Olofsson Bagge, MD, PhD    +46 31 3428207    roger.olofsson@surgery.gu.se   
Principal Investigator: Roger Olofsson Bagge, MD, PhD         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
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Responsible Party: Roger Olofsson Bagge, Associate professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03376126    
Other Study ID Numbers: MI-ILP
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roger Olofsson Bagge, Sahlgrenska University Hospital, Sweden:
isolated limb perfusion