RecruitingNot ApplicableNCT04052893

DFS and QOL After Modified Radical Mastectomy vs. Expanded Mckissock Surgery for EIC of the Breast

Postoperative Disease-free Survival and Quality of Life After Modified Radical Mastectomy Versus Expanded Mckissock Surgery for Extensive Intraductal Carcinoma of the Breast: a Prospective Cohort Study Protocol


Sponsor

Shengjing Hospital

Enrollment

200 participants

Start Date

Oct 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Extensive intraductal carcinoma of the breast refers to a type of breast cancer in which ≥ 25% of ductal carcinoma in situ is present in invasive tumors and there is a scattered distribution of ductal carcinoma in situ (DCIS) in or around the invasive carcinoma. Compared with DCIS negative for extensive intraductal component, DCIS positive for extensive intraductal component is not sensitive to radiotherapy. Mckissock surgery was applied in breast-conserving surgery for breast cancer in 2016. Jianyi Li and the team members (Shengjing Hospital of China Medical University, Shenyang, China) applied this technique in breast-conserving surgery with preservation of the nipple-areola complex. This surgical technique is suitable for low-grade malignant tumors and has better prognosis than radical mastectomy. The purpose of this study is to investigate postoperative disease-free survival and quality of life after modified radical mastectomy versus expanded Mckissock surgery for extensive intraductal carcinoma of the breast. Results from this study will indicate the efficacy of expanded Mckissock surgery in the treatment of extensive intraducatal carcinoma of the breast.


Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two surgical approaches for postmenopausal women with a specific type of extensive non-invasive breast cancer (called DCIS — ductal carcinoma in situ): standard modified radical mastectomy versus a nipple-sparing procedure called the Expanded McKissock technique, which may better preserve body image while still removing the cancer. **You may be eligible if...** - You are a postmenopausal woman with extensive ductal carcinoma in situ (DCIS) confirmed by biopsy - Your cancer does not involve the nipple (confirmed by MRI) - You have a bra cup size of B or larger - You have given written informed consent **You may NOT be eligible if...** - Your cancer involves the nipple directly or tested positive at the nipple margin on two tests - You have nipple discharge with blood - You have cancer in both breasts simultaneously - You have inflammatory breast cancer or distant spread (metastasis) - You have had prior chest radiation or have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREExpanded Mckissock surgery

Expanded Mckissock surgery: (1) According to patient's preoperative imaging results and subjective expectations of their own breast morphology, the incision design and breast surface marking will be performed under the standing position. (2) After general anesthesia, the upper limbs will be abducted, and the upper body will be tilted by 15°-20° to dermatize the labeled skin around and below the areola. (3) The medial and lateral flaps will be dissociated to remove the total gland with nipple and areola preserved. (4) The cutting-edge of nipple-areola complex will be sent for cancer screening. The axillary lymph node biopsy or cleaning will be performed along the outer edge of the pectoralis major muscle. (5) The vertical subcutaneous pedicle flaps will be W-folded, and the flaps on both sides will be pulled to the vertical pedicle to reshape the breast. During this process, the breast and armpit drainage tubes will be indwelled.

PROCEDUREModified radical mastectomy

The patients will be placed in the supine position. After intravenous anesthesia, the tumor boundary will be marked and the breast will be removed. The vertical subcutaneous pedicle flaps will be W-folded, and the flaps on both sides will be pulled to the vertical pedicle to reshape the breast. During this process, the breast and armpit drainage tubes will be indwelled.


Locations(3)

General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group

Benxi, Liaoning, China

Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute

Shengyang, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

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NCT04052893


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