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To explore the accuracy of a new intraoperative cell detection technique in nipple sparing areola complex (NAC) mastectomy for breast cancer: a parallel controlled study

To explore the accuracy of a new intraoperative cell detection technique in nipple sparing areola complex (NAC) mastectomy for breast cancer: a parallel controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101740
Enrollment
Unknown
Registered
2025-04-29
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Gold Standard Group:Paraffin pathology interpretation
ES assisted preservation of nipple areola complex (NAC) in mastectomy (NSM):ES interpretation: performed by a breast surgeon and pathologist after at least one hour of ES training
Frozen pathological interpretation group for routine assisted preservation of nipple areola complex (NAC) in mastectomy:Conventional frozen pathological interpretation

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age over 18 years old; 2.Patients diagnosed with breast cancer who meet the criteria of nipple areola complex (NAC) preserving mastectomy evaluated by doctors; 3.Not receiving radiation therapy before surgery; 4.The subjects voluntarily sign the informed consent form or are exempted from signing after review and approval by the ethics committee;

Exclusion criteria

Exclusion criteria: 1.Intraoperative evaluation of patients who changed to other breast cancer operations; 2.Unable to obtain paraffin pathology report; 3.Intraoperative dye allergy; 4.Patients with clinical or imaging evidence of nipple/areola involvement before surgery, including Paget's disease, nipple haemorrhage, inflammatory breast cancer, and/or imaging results suggest that the nipple or tissues under the areola are involved in malignant lesions, and retaining NAC cannot obtain a negative margin; 5.Accompanied with hypertension, diabetes and other basic diseases, smoking, and surgery under areola; 6.The anatomical characteristics of the breast itself, such as large and sagging breasts (NAC distance from the folds below the breast>8 cm, distance from the sternotomy to the nipple>27 cm);

Design outcomes

Primary

MeasureTime frame
Accuracy;

Secondary

MeasureTime frame
Postoperative complications;Operational efficiency;

Countries

China

Contacts

Public ContactYu Yang

Zhejiang Cancer Hospital

yuyangkaiyu@163.com+86 571 8812 2002

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026