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A National Multicenter Prospective Cohort Study Scheme of Breast Cancer Endoscopic Subcutaneous Resection Combined with Prosthetic ± patch Reconstruction versus Open Prosthetic ± patch Reconstruction

A National Multicenter Prospective Cohort Study Scheme of Breast Cancer Endoscopic Subcutaneous Resection Combined with Prosthetic ± patch Reconstruction versus Open Prosthetic ± patch Reconstruction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047862
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

Breast Cancer

Interventions

Group B: Open Subcutaneous Resection Combined with Prosthetic ± patch Breast Reconstruction:Formulating the surgical method According to the stage of breast cancer, the appearance of the breast and th
Group A: Endoscopic Subcutaneous Resection Combined with Prosthetic ± patch Breast Reconstruction:Formulating the surgical method According to the stage of breast cancer, the appearance of the breast

Sponsors

the West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The preoperative histopathological examination is clearly diagnosed as breast cancer, the clinical stage is 0-II, and the patients with stage III breast cancer can undergo simple subcutaneous resection after downstaging by neoadjuvant chemotherapy; 2. Patients with non-inflammatory breast cancer and breast eczema-like cancer; 3. Patients whose tumor is confined to the gland but does not invade the skin and pectoralis major fascia through physical examination and imaging examination, no fusion of axillary lymph nodes, and no distant metastasis; 4. The primary tumor is multiple lesions, or patients with contraindications to radiotherapy (such as systemic lupus erythematosus) are not suitable for breast conserving surgery; 5. Patients who refuse breast conserving surgery and radiotherapy and have cosmetic needs; 6. Patients with no serious comorbid diseases and no obvious abnormality in the function of important organs.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating female patients; 2. Paget disease of the nipple, inflammatory breast cancer; 3. The maximum diameter of the tumor is more than 5cm; 4. The distance from the tumor to the nipple is less than or equal to 2cm; 5. Patients participating in other studies; 6. Patients with severe organ dysfunction who cannot tolerate general anesthesia; 7. Patients with acute or severe infection or acute exacerbation of chronic infection; 8. Patients with uncontrolled primary diseases of the heart, lung, brain, kidney and other important organs; 9. Patients who are in critical condition and it is difficult to make an exact evaluation of the effectiveness and safety of surgery.

Design outcomes

Primary

MeasureTime frame
(BREAST-Q) Postoperative Assessment Score;Incidence of Complications;

Secondary

MeasureTime frame
Life Quality;Economic Costs;Time Costs;

Countries

China

Contacts

Public ContactDu Zhenggui

the West China Hospital of Sichuan University

docduzg@163.com+86 13880768222

Outcome results

None listed

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