Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESirius Pintution
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.
DEVICEHydroMARK (C) 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.
Sponsors
Constanze Elfgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A prospective, randomized multi-centre trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication: Patients undergoing lymph node marking before targeted axillary dissection due to suspicious lymph nodes or confirmed lymph node metastasis in breast cancer patients * Female participants ≥ 18 years of age * The subject was informed about the project and gave her written informed consent to use her data and samples for this project. * BMI \< 30 * Indication for neoadjuvant chemotherapy
Exclusion criteria
* Not fulfilling inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare clinical manageability, efficacy, safety, and sufficiency of two lymph node marking systems (HydroMark Clip versus Sirius Pintuition) | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failure rate (unsuccessful localisation of the marked lymph node) | 6 months | 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. |
| Incidence of complications of both methods used for lymph node marking. | 6 months | This outcome measures the safety of both methods during the implantation of the randomised marker, excision surgery of the lymph node and postoperative period. |
| Adverse events | 6 months | This outcome assesses adverse events caused by either lymph node marker during implantation and excision of the marker and within the postoperative period. |
| Satisfaction of the performing Surgeon concerning the handling of the marking technique documented in the Case Report Form. | 6 months | This outcome measures the satisfaction of the performing surgeon concerning the handling of the lymph node marking technique during implantation and excision surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative complications and postoperative adverse events. | 6 months | The safety outcome variables include allergic reactions, bleeding, bruising, dislocation, pain, scar, and very rare events such as lymphedema or neurologic damages. |
Countries
Switzerland
Outcome results
None listed