跳至主要内容
临床试验/CTRI/2024/12/077661
CTRI/2024/12/077661尚未招募不适用

Comparison of Oncological and Cosmetic Outcomes in patients undergoing Oncoplastic vs Conventional (non-Oncoplastic) Breast Conservation Surgery

SGPGI LUCKNOW1 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2024年12月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
376
试验地点
1
主要终点
To compare Margin infiltrating rate (MIR) i.e, positive margins on Frozen section biopsy between both groups

研究概览

简要总结

Breast cancer is among the most prevalent malignancies affecting women worldwide. Breast conservation  surgery(BCS) is the preferred surgical treatment combined with radiation therapy for eligible early(EBC) and selected locally advanced breast cancer(LABC) patients (1). Achieving sound oncologic outcomes are of paramount importance. Preserving quality of life is pivotal too, with maintaining breast symmetry, shape, contour being crucial objectives. Oncoplastic breast surgery(OPS) techniques are believed to help achieving these goals to greater extent than conventional non-oncoplastic(nOPS) BCS (2).

After neoadjuvant chemotherapy (NACT), breast conservation surgery (BCS) remains a safe option even for large tumors and locally advanced breast cancer (LABC), although many patients may require oncoplastic procedures to achieve satisfactory cosmetic results (3). In settings where patients commonly present with large breast cancers or LABC, the benefits of BCS can be extended to a majority, aided by NACT, without compromising cure rates. Performing a post-NACT wide local excision (WLE) that extends beyond the marked pre-NACT margins can result in clear, uninfiltrated margins in 95% of cases. Conversely, relying on post-NACT margins alone to guide WLE may lead to infiltrated margins in 35% of patients, some of which could remain undetected, thereby increasing the risk of local recurrence (4). A novel method using sterile silver wire markers to delineate tumor margins has proven to be a safe, cost-effective, and practical approach, facilitating safe BCS in a substantial proportion of LABC patients. Additionally, the use of intraoperative frozen section histology (IFSH) enables oncologically complete BCS in a single step for most patients, offering significant cost savings by reducing the need for reoperations, and minimizing patient anxiety and delays in adjuvant treatment (5).

REFERENCES:

1.      Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71(1):7-33.

2.       Morrow M, Li Y, Alderman AK, Jagsi R, Hamilton AS, Graff JJ, et al. Access to breast reconstruction after mastectomy and patient perspectives on reconstruction decision making. JAMA Surg. 2014;149(10):1015-21.

1.      Agarwal G, Sonthineni C, Mayilvaganan S, Mishra A, Lal P, Agrawal V. Surgical Outcomes of Primary Versus Post-Neoadjuvant Chemotherapy Breast Conservation Surgery: A Comparative Study from a Developing Country. World J Surg. 2018 May;42(5):1364-74.

2.      Aggarwal V, Agarwal G, Lal P, Krishnani N, Mishra A, Verma AK, Mishra SK. Feasibility study of safe breast conservation in large and locally advanced cancers with use of radiopaque markers to mark pre-neoadjuvant chemotherapy tumor margins. World J Surg. 2008 Dec;32(12):2562-9.

3.      Agarwal G, Sattavan S, Vishvak Chanthar KMM, Kumar A, Sabaretnam M, Chand G, Mishra A, Agrawal V. Cost-Efficacy Analysis of Use of Frozen Section Histology for Margin Assessment During Breast Conservation Surgery in Breast Cancer Patients. World J Surg. 2023 Oct;47(10):2457-63

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 90.00 Year(s)(—)
性别
Female

入选标准

  • 1 Female patients diagnosed with early breast cancer (EBC) or locally advanced breast cancer (LABC) who have undergone breast conservation surgery at SGPGIMS.
  • 2 Patients who are candidates for breast-conserving surgery (BCS), either as primary surgery or after neoadjuvant chemotherapy (NACT).
  • 3 Patients who consent to participate in the study and complete the required questionnaires.

排除标准

  • •Patients with Metastatic Breast cancer •Patients requiring mastectomy due to tumor size, multifocality, extensive microcalcifications, or any other clinical factors •Insufficient data or follow up.

结局指标

主要结局

To compare Margin infiltrating rate (MIR) i.e, positive margins on Frozen section biopsy between both groups

时间窗: At surgery

To compare Ipsilateral breast tumor recurrence (IBTR) rate between both groups.

时间窗: At surgery

次要结局

  • To Compare patient satisfaction regarding breast shape, volume, symmetry, scar and overall satisfaction(To compare the re-excision rate between both groups)

研究者

发起方
SGPGI LUCKNOW
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Gaurav Agarwal

SGPGI

研究点 (1)

Loading locations...

相似试验