Comparison of two methods (Magnetic Marker and standard metal clip) used for localisation and extraction of lymph nodes in Targeted Axillary Dissection (TAD) in patients with breast cancer.This Project will investigate and compare the duration of intervention, detection rate and safety. The participants will be randomized into two groups of equal size.
This Project will investigate and compare the duration of intervention, detection rate and safety of two methods (Magnetic Sirius Pintuition Marker and standard metal clip) used for the localisation and extraction of lymph nodes in Targeted Axillary Dissection (TAD). The participants will be randomized into two groups of equal size. The groups differ in terms of the method used to mark the lymph nodes prior to TAD. One group will receive a metal clip (HydroMARK© Clip), which will be localized and extracted during the tailoring surgery. Intraoperative Ultrasound is used to localize the clip. This method is considered as standard practice today. The second group will receive Metal Clip (Sirius Pintuition) to localize axillary lymph nodes during TAD. Intraoperative localization of the lymph node will be conducted using a hand-held probe. Successful localization of the lymph node, duration of the intervention (beginning of the localization until successful extraction) and adverse effects will be documented.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
The intervention studies a metal Clip (Sirius Pintution) to localize axillary lymph nodes during TAD. Intraoperative localization of the lymph node will be conducted using a hand-held probe identifying the clip.
The control intervention is a metal clip (HydroMARK© Clip), which will be localized and extracted during the tailoring surgery. Intraoperative Ultrasound is used to localize the clip. This method is considered as standard practice today.
Brustzentrum Kantonsspital Baden
Baden, Canton of Aargau, Switzerland
Brustzentrum Bern Biel
Bern, Switzerland
Brustzentrum Ostschweiz
Sankt Gallen, Switzerland
Brust-Zentrum Zürich AG
Zurich, Switzerland
To compare clinical manageability, efficacy, safety, and sufficiency of two lymph node marking systems (HydroMark Clip versus Sirius Pintuition)
The primary outcome is the efficacy of both methods for lymph node marking. Efficacy is defined as performance time during the surgery from skin incision (either with hooked wire or scalpel) until the complete excision of the marked lymph node. Time is measured in minutes. Manageability includes process performance of the marker insertion (questionnaire for the study physician: "did you experience problems or barriers in inserting the marker?"; "if yes, what kind of?"). Safety is also observed via the questionnaire ("did your patient experience adverse events? bleeding, seroma, (...), other?"). This is also true for sufficiency ("Did you acieve a successful lymph node marking?"; "Have you been able to localize the marker during the surgery or has it been dislocated?"; "Did you manage to remove the marked lymph node including the marker").
Time frame: 6 months
Failure rate (unsuccessful localisation of the marked lymph node)
As a secondary outcome, the failure rate (unsuccessful localisation of the marked lymph node) will be measured. As the failure rate is supposed to be low in general, this topic is not the focus of our study.
Time frame: 6 months
Incidence of complications of both methods used for lymph node marking.
This outcome measures the safety of both methods during the implantation of the randomised marker, excision surgery of the lymph node and postoperative period.
Time frame: 6 months
Adverse events
This outcome assesses adverse events caused by either lymph node marker during implantation and excision of the marker and within the postoperative period.
Time frame: 6 months
Satisfaction of the performing Surgeon concerning the handling of the marking technique documented in the Case Report Form.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
This outcome measures the satisfaction of the performing surgeon concerning the handling of the lymph node marking technique during implantation and excision surgery.
Time frame: 6 months