Skip to content

A multicenter prospective cohort clinical study of endoscope-assisted comparative open nipple-preserving areola subcutaneous adenectomy plus stage I prosthesis reconstruction in early breast cancer

A multicenter prospective cohort clinical study of endoscope-assisted comparative open nipple-preserving areola subcutaneous adenectomy plus stage I prosthesis reconstruction in early breast cancer - A multicenter prospective cohort study of endoscopic subcutaneous adenectomy for breast cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065426
Enrollment
Unknown
Registered
2022-11-04
Start date
2025-03-24
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Breast cancer

Interventions

Research Group (Endoscopic Group):Not mentioned
Control group (Open Group):Not mentioned

Sponsors

Department of Breast and Thyroid Surgery, the First Affiliated Hospital of Army Military Medical University (Southwest Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age: 18 -70 years old; 2) Pathologically confirmed as invasive breast cancer; 3) T1-2N0M0 was unwilling to undergo breast-conserving surgery or T3N0M0 was evaluated by clinicians as still not suitable for breast-conserving surgery after neoadjuvant therapy; 4) Those with breast volume less than 500 ml and no severe ptosis; 5) No imaging or clinical evidence was found before the operation that the tumor invaded the nipples, areolas and subcutaneous tissues. 6) The preoperative ECOG physical condition score ranged from 0 to 1 point; 7) Preoperative ASA score I-III; 8) Undergo breast prosthesis reconstruction, agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Bilateral breast cancer or contralateral breast requires prophylactic resection; 2) Had received less than 4 cycles of non-standard comprehensive anti-tumor treatment before enrollment; 3) Severe dysfunction of important organs such as the heart, liver, lungs and kidneys, which cannot tolerate anesthesia, surgery and necessary comprehensive treatment; 4) History of malignant tumors, or other malignant tumors discovered through examination (excluding thyroid cancer, basal cell carcinoma of the skin, etc.); 5) The patient is currently or occasionally smoking; 6) After the clinical doctor made a detailed inquiry about the patient's past medical history and a comprehensive assessment, it was found that the patient suffered from a serious mental disorder and was unable to fully understand the research content and cooperate to complete the trial. 7) A history of unstable angina pectoris or myocardial infarction, cerebral infarction or cerebral hemorrhage within 6 months; 8) Concurrent major surgical treatment for other diseases is required; 9) Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Surgical efficacy;Surgical safety;

Countries

China

Contacts

Public ContactJiang Jun

Department of Breast and Thyroid Surgery, the First Affiliated Hospital of Army Military Medical University (Southwest Hospital)

jcbd@medmail.com.cn+86 135 0831 9495

Outcome results

None listed

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