MALLORCA - Trial (Surgical MArker LocaLisation OR Clip and Wire Application for Targeted Axillary Dissection in Node Positive Breast Cancer Patients) A Prospective, Randomized Multi-centre Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- To compare clinical manageability, efficacy, safety, and sufficiency of two lymph node marking systems (HydroMark Clip versus Sirius Pintuition)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not fulfilling inclusion criteria
结局指标
主要结局
To compare clinical manageability, efficacy, safety, and sufficiency of two lymph node marking systems (HydroMark Clip versus Sirius Pintuition)
时间窗: 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").
次要结局
- Failure rate (unsuccessful localisation of the marked lymph node)(6 months)
- Incidence of complications of both methods used for lymph node marking.(6 months)
- Satisfaction of the performing Surgeon concerning the handling of the marking technique documented in the Case Report Form.(6 months)
- Adverse events(6 months)
研究者
Constanze Elfgen
Study Principal Investigator
Brust-Zentrum AG