Prospective Randomized Control Study About the Effect of Postmastectomy Radiation Therapy on Capsular Contracture in Patients With Prepectoral or Subpectoral Implant-based Breast Reconstruction: PREPER Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 114
- 主要终点
- Rate of capsular contracture (grade 3 or higher) (%) by Baker's scale
研究概览
简要总结
The purpose of this study is to prospectively compare and analyze the incidence of complications in patients undergoing postmastectomy radiation therapy after breast reconstruction with subpectoral and prepectoral placement of implant. Investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in lower risk of capsular contracture after postmastectomy radiation therapy(PMRT) compared with acellular dermal matrix(ADM)-assisted implant-based breast reconstruction with subpectoral implant placement.
详细描述
OUTLINE: This is a single center randomized clinical trial. Participant recruitment and enrollment will occur at Gangnam Severance Hospital Breast Cancer Center for 4 years, followed by one year of follow up data collection and analysis.
Arm I (Prepectoral): immediate ADM-assisted implant-based breast reconstruction with prepectoral implant placement.
Arm II (Subpectoral): immediate ADM-assisted implant-based breast reconstruction with subpectoral implant placement.
This clinical study is aimed at patients who have been diagnosed with breast cancer and who have undergone a total mastectomy for the therapeutic indication, and who are planning to undergo implant based reconstruction and postmastectomy radiotherapy.
It will be carried out prospectively in a single institution, and the study will be divided into two groups, subpectoral implant and prepectoral implant, according to the reconstruction method.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age over 19 years old
- •Histologically confirmed diagnosis of unilateral breast cancer
- •Mastectomy (nipple or skin sparing mastectomy) candidate for therapeutic indication
- •Patient undergoing immediate implant based breast reconstruction
排除标准
- •Underlying medical condition: for example, (AST or ALT >100U/L, inadequate renal function; eGFR < 30ml/min, congestive heart failure; New York Heart Association III-IV)
- •Prior history of radiotherapy on the affected side of breast or chest wall before mastectomy
- •History of a known additional malignancy Note: Participants with melanoma of skin, low grade thyroid cancer are not excluded.
- •Not able to provide informed consent (Illiterate, foreigners, etc.)
结局指标
主要结局
Rate of capsular contracture (grade 3 or higher) (%) by Baker's scale
时间窗: 6 months after the completion of PMRT
To compare the frequency of grade 3 or higher contracture development analyzed by using Baker's scale at 6 months after the completion of PMRT.
Rate of capsular contracture (grade 3 or higher) (%) by 2D shear elastography
时间窗: 6 months after the completion of PMRT
To compare the frequency of grade 3 or higher contracture development analyzed by using 2D shear-wave elastography at 6 months after the completion of PMRT.
次要结局
- Rate of capsular contracture (grade 3 or higher) (%) in long term follow up(1 year after the completion of PMRT)
- Patient reported outcome(1 year after the completion of PMRT)
研究者
Joon Jeong
professor
Gangnam Severance Hospital