无疤面的高级乳房扩展肿瘤成形术:Scarabeo研究 (ScarABEO)
Breast conserving surgery followed by radiotherapy is the gold standard treatment for early breast cancer. Cases with unfavorable tumor volume to breast volume ratio or challenging localizations are at higher risk of margin infiltration or poor aesthetic outcomes. While margin infiltration represents one of the strongest predictors of local recurrence, unappealing cosmetic results may significantly impair survivors' quality of life. Over the past two decades, the adoption of oncoplastic breast conserving surgery (OBCS) techniques has shown promise in improving both oncological and aesthetic outcomes after breast cancer surgery. Partial breast volume reconstruction (PBR) after OBCS is obtained through volume displacement (which involves remodelling and redistributing glandular tissue) and volume replacement (when the volume used to reconstruct the defect comes from an extramammary site) techniques.
One of the greatest examples of volume replacement techniques in breast surgery involves the use of chest wall perforator flaps (CWPF). The use of these well-vascularized dermo-adipose flaps offers oncologically safe wide resection while obtaining excellent cosmetic outcomes. It is particularly suitable for patients with non-ptotic small to medium-sized breasts and cases with an unfavorable tumor volume to breast volume ratio. CWPFs can decrease mastectomy rates in breast cancer surgery, thus avoiding the disadvantages associated with implant-based reconstruction. Consequently, the need of contralateral simmetrization is also diminished.
CWPFs are vascularized by perforator arteries that arise from the chest wall (mainly branches of the axillary artery, or intercostal arteries deriving from the internal mammary artery). While cadaver labs and radiologic studies demonstrated a reliable and coherent localization of perforator arteries, the use of Doppler Ultrasound is often required to localize the perforators and test their reliability. Compared to the traditional myocutaneous flaps (such as the latissimus dorsi flap), CWPFs spare the underlying muscles minimizing donor site morbidity and enabling rapid post-operative recovery, low post-operative complication rates, post-operative pain, and loss of function. All these advantages may result in high levels of patients' satisfaction. Additionally, CWPFs avoid the microsurgical anastomoses required for free flaps.
All breast quadrants defects could be restored with CWPFs, with the Thoraco-Dorsal Artery Perforator (TDAP), Lateral-Thoracic Artery Perforators (LTAP) and Lateral Intercostal Artery Perforator (LICAP) Flaps particularly suitable for reconstructing lateral quadrant; the Anterior Intercostal Artery Perforator (AICAP) Flap for the lower quadrants and the Internal Mammary Artery Perforator (IMAP) Flaps for volume defects at inner quadrants.
Although existing literature reports promising results, the use of CWPFs remains emerging, and OBCS with CWPFs is currently limited to select high-volume breast centers. The collection of robust clinical data is essential to validate these potential advantages and facilitate the broader adoption of this technique.
This multicentric retrospective observational study aims to collect evidence about the surgical and oncological outcomes of OBCS with CWPFs, to evaluate the potential benefits associated with the use of this innovative technique.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Massimo Ferrucci
- 电话号码:+39 3331779209
- 邮箱:massimoferrucci@gmail.com
学习地点
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Padova、意大利、35128
- 招聘中
- Veneto Institute of Oncology
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接触:
- Massimo Ferrucci
- 电话号码:+393331779209
- 邮箱:massimoferrucci@gmail.com
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接触:
- Daniele Passeri
- 电话号码:+393333839397
- 邮箱:daniele.passeri.1995@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Female Patients who underwent OBCS with CWPFs for breast cancer, with at least one-year follow-up
描述
Inclusion Criteria:
- Patients treated with BCS combined with CWPFs for primary stage I-III invasive cancer (IC) or ductal carcinoma in situ (DCIS);
- Patients treated during the last 10 years (2015-2025);
- Patients aged 18 years or more;
- Cases with at least one-year follow-up.
Exclusion Criteria:
- Male Patients;
- Patients aged less than 18 years;
- Patients who underwent traditional breast conserving surgery or OBCS with displacement techniques;
- Patients who underwent mastectomy;
- Patients who underwent implant-based reconstruction;
- Patients with unresectable breast cancer or metastatic disease;
- Patients who were lost during follow-up.
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:RETROSPECTIVE
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Margin infiltration rate
大体时间:Perioperative
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Margin infiltration rate in Patients with breast cancer or ductal carcinoma in situ who underwent Oncoplastic Breast Conserving Surgery with Chest Perforator Flaps |
Perioperative
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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无病生存
大体时间:两年
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两年
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总切除量和最终乳房量比
大体时间:围手术期
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围手术期
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术后并发症发生率
大体时间:长达24周
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长达24周
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术后乳房对称性
大体时间:一年
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一年
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总体生存
大体时间:两年
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两年
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Re-excisions rate
大体时间:Up to 24 weeks
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Re-excisions rate due to positive margins rate on surgical specimen |
Up to 24 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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