Status:
UNKNOWN
Prospective Pilot Study ANDPrecise
Lead Sponsor:
The Netherlands Cancer Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This study aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an ...
Detailed Description
Axillary clearance in breast cancer is usually performed by using a drain to prevent seroma formation and to support obliteration of the dead space in the axillary carry out. The hypothesis made in th...
Eligibility Criteria
Inclusion
- Indications for axillary clearance can be a tumor positive sentinel node or tumor positive lymph nodes proven by ultrasound or fine needle aspiration cytology.
- For this pilot, only patients undergoing breast conserving surgery are eligible.
- Axillary clearance can be performed after previous sentinel node procedure, at the same operation, and after neo-adjuvant chemo therapy, and as secondary procedure in case of axillary relapse after previous treatment for breast cancer.
Exclusion
- Patients undergoing a modified radical mastectomy including an axillary clearance.
- Preoperative preexisting seroma.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02292407
Start Date
June 1 2012
End Date
June 1 2018
Last Update
November 17 2014
Active Locations (1)
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1
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, Netherlands, 1066CX