Impact of Radiofrequency Ablation on Surgical Margins in Early Stage of Malignant Breast Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intraoperative free margins (distance between the tumor and the margin in order to indicate if extensions are mandatory.)
研究概览
简要总结
Background/Main objective: Radiofrequency ablation (RFA) is a minimally invasive procedure widespread accepted in the treatment of different tumors, especially in the liver but its benefit is not yet well-known in breast cancer.
Our main objective is to evaluate the usefulness of RFA in < 2cm malignant breast tumors to reduce the proportion of positive margins.
Methodology: The investigator propose a single-center, single-blind, phase I and II randomized controlled trial. Phase I:Security of the cool-tip cluster electrode assessing the potential adverse effects in three stages: initial,intermediate and final. Phase II: Randomized clinical trial, 2 parallel groups with 37 patients in each one.
Experimental group: percutaneous RFA previous to conventional lumpectomy. Control group: conventional surgery with lumpectomy. The number of positive margins in both groups, and the need of extending margin resection will be assessed intraoperatively. Inclusion criteria: women >40 years, infiltrating ductal breast carcinoma by biopsy. The tumor must be unique, visible by ultrasound, smaller than 2cm and located > 1 cm from the chest wall and the skin. Patients will be followed up for a period of two years to assess cosmetic result, short -term and long -term complications and recurrences.
Expected results: The "cool-tip" (cluster) ablation method reduces by at least 30% the risk of intraoperative extensions for positive margins during lumpectomy compared to conventional surgery in breast tumors with a diameter < 2 cm.
Therefore this procedure may reduce the risk of second surgeries and the removed volume of tissue.Consequently the final cosmetic result should be improved.
详细描述
Main objectives of the project:
- To evaluate the usefulness of radiofrequency ablation (RFA) to achieve a lower percentage of positive margins.
- To validate clinically the efficacy and safety of the method in breast tumors smaller than < 2 cm.
Specific objectives of the project:
-
To demonstrate that , after RFA, clear margins are increased in the intraoperative pathological analysis compared to conventional surgery.
-
To quantify the number of positive margins requiring intraoperative extension in each patient, comparing the ratio in both groups.
-
To quantify the percentage of patients requiring intraoperative extension compared in both groups.
-
To demonstrate a reduction in the volume of breast tissue removed after RFA compared to conventional surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast single tumor,
- •Clearly visible by ultrasound,
- •Diameter < 2 cm
- •Located >1 cm from the chest wall and skin;
- •Ductal carcinoma according to previous biopsy,
- •< 20% of intraductal carcinoma
排除标准
- •Breast cancer in men;
- •Personal history of ipsilateral breast cancer;
- •Age <40 years;
- •Pregnancy or breastfeeding;
- •Suspicion of intraductal extension or multifocality by mammography or MRI;
- •Tumour not visible by ultrasound;
- •Diameter > 2 cm;
- •Distance to muscle or skin <1 cm;
- •Lobular carcinoma;
- •Intraductal carcinoma in > 20% of the biopsy sample
- •Patients undergoing neoadjuvant chemotherapy or hormonotherapy.
研究组 & 干预措施
RFA group
A percutaneous (utlrasound-guided) radiofrequency ablation (RFA) of the tumor will be performed by the radiologist under general anesthesia. Immediately after, excision of the tumor with appropriate margin will be accomplished.
干预措施: Radiofrequency ablation (Procedure)
Control group
Normal excision of the tumor according to the protocol
结局指标
主要结局
Intraoperative free margins (distance between the tumor and the margin in order to indicate if extensions are mandatory.)
时间窗: 1 hour
The pathologist performed a macroscopic study of the specimen, measuring the distance between the tumor and the margin in order to indicate if extensions are mandatory.
次要结局
- Security of RFA (Adverse effects and cosmetic result)(15 days)
- Efficacy of RFA (Tumoral viability in the ablation zone)(7 days)
研究者
Amparo Garcia-Tejedor
MD PhD
Hospital Universitari de Bellvitge