Reducing Re-excisions After Breast Conserving Surgery: A Randomized Controlled Trial Comparing the MarginProbe Device in Addition to Standard Operating Procedure Versus Standard Operating Procedure Alone in Preventing Re-excision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- To determine if intraoperative margin assessment after excision of a cancer reduces second operations (reexcision or mastectomy), compared to standard surgical practice by 9 months after primary surgery.
研究概览
简要总结
The new device we are looking at is called the MarginProbe. It is a disposable probe which measures the margins of tissue removed to check they are clear of cancer cells, during breast conservation surgery. After specimen radiology, allows the Surgeon to remove further tissue if necessary, during the same operation if any involved margins are identified. This minimises the need for further repeat operations.
Previous studies carried out elsewhere in the world (USA and Israel) have identified that the probe reduces re-excision rate but there has never been a study in the UK.
The trial involves randomly allocating patients once they are in theatre, to either the MarginProbe procedure after breast conserving surgery and radiology has been completed, or not.
详细描述
Almost 60% of all patients diagnosed with breast cancer (48000 annually in the UK) undergo breast conserving surgery (BCS. Surgical removal of the cancer aims to reduce the risk of local recurrence and patient mortality. In order to minimise the amount of tissue removed, excision up to the cancer-free area (margins) is undertaken. Further surgery, following initial breast cancer surgery, is required in 25% - 30% of patients because of disease found at the edges of the tissue removed.
Reducing the need for further operations benefits patients (by reducing the number of operations required, improving cosmetic outcome and minimising anxiety) and the NHS (by realising economic benefits).
MarginProbe, a disposable probe which measures the margins of tissue removed during breast cancer surgery, allows the surgeon to remove further tissue during the same surgical procedure to clear any involved margins, minimising subsequent re-operations. Four hundred and sixty patients in 6 specialist Breast Units will be randomly allocated after BCS (and specimen radiology), by telephone randomisation, to either:
- MarginProbe assessment of the surgical specimen with re-excision of margins if required;
- Standard BCS (clinical and radiological clear margins) whereby the wound will be closed and the surgery completed (standard UK practice).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-90 years with DCIS or Invasive Breast cancer containing DCIS diagnosed histopathologically.
- •Histologically diagnosed DCIS or invasive lobular cancer in core biopsy (B5a or B5b).
- •Tumour size 1.5cm - 4cm and undergoing breast cancer surgery. Written informed consent.
排除标准
- •Unsuitable for BCS on basis of tumour size (<1.5cm or >4cm) or stage.
- •Radiotherapy contraindicated.
- •No histopathological evidence of DCIS or invasive lobular cancer.
- •Neoadjuvant chemotherapy.
研究组 & 干预措施
Device Arm
Randomized for MarginProbe device to be used during surgical procedure
干预措施: MarginProbe (Device)
Control Arm
Randomized for surgical procedure to happen as per standard care
结局指标
主要结局
To determine if intraoperative margin assessment after excision of a cancer reduces second operations (reexcision or mastectomy), compared to standard surgical practice by 9 months after primary surgery.
时间窗: 9 months post surgery
To determine if the use of the MarginProbe device, after surgical tumour excision and tissue specimen radiography of a breast cancer reduces rates of further surgical re-excision operations (re-excision or mastectomy), when compared to control/standard practice(whereby the wound is closed after radiography showing clear margins).
次要结局
- Cosmetic Outcome(9 months post surgery)
- Quality of Life(9 months post surgery)
- EQ5D(9 months post surgery)
- Total number of re-excisions(9 months post surgery)
- To compare the number of patients in both groups presenting with disease free margins greater than 1mm (circumferentially) after breast cancer surgery, using a laboratory histopathological assessment.(9 months post surgery)