Axillary Reverse Mapping (ARM). Identification of the Arm Lymphatic Pathways in Breast Cancer Surgery to Prevent Breast Cancer Related Lymphedema (BCRL): a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Incidence of Breast Cancer Related Lymphedema (BCRL) after Axillary Lymph Node Dissection (ALND)
研究概览
简要总结
Breast cancer related lymphedema (BCRL) is a debilitating and distressing condition affecting approximately one out of five breast cancer survivors. BCRL is a chronic swelling of the upper arm following axillary lymph nodes dissection, and it is associated to a significant functional, psychological and social morbidity, with an heavy impact on life quality. Several studies reported BCRL incidence between 6.7% and 62.5% for different population cohorts. Randomized clinical trials (RCTs) reported that sentinel lymph node biopsy (SLNB) when compared with axillary lymph node dissection (ALND) leads to a significant reduction in postoperative complications. However, the advent of SLNB does not solve the problem of BCRL with a concrete chance to develop a lymphedema after single SLNB around 7%. Health care cost of BCRL rehabilitative treatment is not available in literature yet. Few studies considered incidence, risk factors and treatment costs of BCRL among working-age women after breast cancer treatment, reporting that BCRL population had significantly higher rehabilitative medical costs ($14,877 to $23,167) with twice as much risk to develop BCRL complications, such as lymphangitis or cellulitis when compared to "BCRL free" population (OR = 2.02, P = .009).
Axillary reverse mapping (ARM) procedure claims to map and preserve arm lymphatic drainage during ALND and/or during SLNB, reducing BCRL development. ARM is developed as result of assumption that arm's lymphatic pathway is not involved by metastatic tumor cells of the primary breast cancer. However, when the arm lymph node correspond to the SLN it should be removed for correct tumor staging, thus a lymphatic drainage disruption onset will be expected with BCRL risk increase.
During the ARM procedure, a fluorescence imaging technique (photodynamic procedure) is useful for detecting lymphatic drainage of the upper limb and it allows in differentiating the fluorescent ARM node from the SLN identified by the radioguided technique (99mTC-Nanocoll).
详细描述
The investigators will conduct a randomized clinical trial (RCT) at the S. Anna University Hospital of Ferrara (Italy) on consecutive patients undergoing SLNB for breast cancer and subsequent ALND in case of SLN metastases. Eligible patients for radioguided sentinel lymph node biopsy (rSLNB) will be randomly divided in two groups: 1) experimental group in which patients undergoing rSLNB and ARM photodynamic procedure; and, in case of SLN metastases, subsequent ALND with ARM node preservation; 2) control group in which patients undergoing rSLNB and ARM photodynamic procedure; and, in case of SLN metastases, subsequent ALND with ARM node removal.
Consent procedure
Patients will be visited in the outpatient clinic by one of the treating surgeon, who will approach the subject and explain the study. If the patient is interested in participating, further details will be provided and consent will be obtained.
Experimental design
Step 1
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will be randomized before the SLNB procedure. Due to the type of intervention, the blinding of the treating surgeon will not be possible, thus the surgeon will be aware of both the intraoperative crossover between ARM lymph node and SLN (secondary outcome) and the allocation to ARM lymph node preservation or removal. Data about BCRL (primary outcome) will be collected by the physiatrist and the physiotherapist that will be blinded about the allocation (ARM lymph node preservation/removal) and the crossover between SLN of the breast and the arm's lymph node. The assessment of lymphoscintigraphic subclinical modification in the arm lymphatic drainage after SLNB and ALND (secondary outcomes) will be performed by a blinded nuclear medicine physician that will not be aware of the allocation (ARM lymph node preservation/removal) and the crossover between ARM lymph node and breast's SLN.
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
- •T1-T2 stage breast cancer
排除标准
- •axillary lymph node metastasis;
- •previous surgery on the ipsilateral axilla;
- •neoadjuvant chemo-radiotherapy;
- •presence of primitive lymphedema of the arm;
- •allergy to Iodine, thyroid disease, renal and hepatic impairment (for issues related to Indocyanine Green)
- •pregnancy;
- •patients refusing to participate in the study.
研究组 & 干预措施
ARM lymph node preservation
All patients will be sent to both rSLNB and photodynamic Axillary Reverse Mapping (ARM) to evaluate the crossover between SLN and ARM lymph node. In case of SLN metastases, an ALND with ARM lymph node preservation will be performed.
干预措施: Axillary Reverse Mapping (ARM) (Procedure)
ARM lymph node removal
All patients will be sent to both rSLNB and photodynamic Axillary Reverse Mapping (ARM) to evaluate the crossover between SLN and ARM lymph node. In case of SLN metastases, an ALND with ARM lymph node removal will be performed.
干预措施: Axillary Reverse Mapping (ARM) (Procedure)
结局指标
主要结局
Incidence of Breast Cancer Related Lymphedema (BCRL) after Axillary Lymph Node Dissection (ALND)
时间窗: From the day of surgery to 12 months after surgery
Incidence of BCRL in patients in whom the ARM lymph node is preserved compared to those in which it is removed. Clinically follow-up will include the clinical presentation (pain, integumentary abnormalities, paresthesia, hypoesthesia, neuro-vascular deficits), standardized measurement of 7 records \[diameters of the upper limb (hand, wrist, 15 cm and 10 cm distally to olecranon, elbow (olecranon), 10 cm and 15 cm proximally to olecranon)\] and final conversion into volumes.
次要结局
- Lymphoscintigraphic sub-clinical modifications of arm lymphatic drainage after ALND(The day before ALND and at 60 days after ALND)
- Crossover between Sentinel Lymph Node (SLN) of the Breast and the ARM lymph node(Intraoperatively)
- Incidence of Breast Cancer Related Lymphedema (BCRL) after Sentinel Lymph Node Biopsy (SLNB) alone(From the day of surgery to 12 months after surgery)
研究者
Paolo Carcoforo
MD
University Hospital of Ferrara