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Reverse Expansion & Autologous Fat Graft Breast Reconstruction: a Prospective, Single Center, Single Arm Phase II Pilot Study

Reverse Expansion & Autologous Fat Graft Breast Reconstruction: a Prospective, Single Center, Single Arm Phase II Pilot Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031317
Enrollment
Unknown
Registered
2020-03-27
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

Breast Cancer

Interventions

single arm:reverse expansion & autologous fat graft breast reconstruction

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Non-pregnant women, BMI >= 18.5, aged 18-65 years; 2. Patients sign informed consent; 3. Patients with unilateral breast cancer; 4. Those patients diagnosed with early operable breast cancer by puncture, including carcinoma in situ, lobular carcinoma in situ; 5. Patients who are not suitable for and refuse the radical mastectomy; 6. Those who accept total subcutaneous mastectomy with nipple sparing areola; 7. Patients with the intention of breast reconstruction.

Exclusion criteria

Exclusion criteria: 1. Patients with positive axillary lymph nodes or confirmed by puncture; 2. Patients who need postoperative adjuvant radiotherapy; 3. Patients who need new adjuvant treatment; 4. Patients with local advanced breast cancer and inflammatory breast cancer; 5. Patients with tumors involving skin, pectoralis major and other adjacent tissues indicated by body and imaging; 6. Patients with visceral metastasis indicated by physical examination and imaging; 7. Patients with cancer cell invasion in the posterior tissue of the nipple, which was indicated by pathology during and after operation; 8. Patients with MRI contrast agent, lidocaine injection and allergic history; 9. Patients with heart, lung, liver and kidney, coagulation dysfunction, which should not be included in the group judged by the clinician.

Design outcomes

Primary

MeasureTime frame
BREAT-Q;

Secondary

MeasureTime frame
Retention rate;Complications;

Countries

China

Contacts

Public ContactZhu Liling

South Hospital of Sun Yat-Sen Memorial Hospital of Sun Yat sen University

vivovivo@163.com+86 13828492475

Outcome results

None listed

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