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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

Tracking Information
First Submitted Date December 8, 2017
First Posted Date December 18, 2017
Last Update Posted Date December 18, 2017
Actual Study Start Date June 1, 2016
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2017)
Conversion to open surgery [ Time Frame: 1 day ]
Number of minimal-invasive procedure that will be converted to open surgery (per cent)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 12, 2017)
  • Response [ Time Frame: 3 months ]
    Clinical response rate according to WHO criteria.
  • Complications [ Time Frame: 30 days ]
    Complications according to Clavien-Dindo
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Minimally-Invasive Isolated Limb Perfusion
Official Title Minimally-Invasive Isolated Limb Perfusion
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients scheduled for isolated limb perfusion.
Condition Isolated Limb Perfusion
Intervention Other: Minimal-invasive isolated limb perfusion
Minimal-invasive isolated limb perfusion
Study Groups/Cohorts MI-ILP
Intervention: Other: Minimal-invasive isolated limb perfusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 12, 2017)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03376126
Other Study ID Numbers MI-ILP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Roger Olofsson Bagge, Sahlgrenska University Hospital, Sweden
Study Sponsor Sahlgrenska University Hospital, Sweden
Collaborators Not Provided
Investigators Not Provided
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date December 2017