Comparing the efficacy of 3D-Printed-Mold-Guided breast conserving surgery with the regular breast conserving surgery: a prospective multicenter randomized controlled trial.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021121

Enrollment

Unknown

Registered

2019-01-29

Start date

2019-02-12

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

breast cancer

Interventions

intervention group:3D-Printed-Mold-Guided breast conserving surgery

Control group:regular breast conserving surgery

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female aged 18-70 years; 2. Surgery plan has been made, and surgery informed consent has been signed; 3. Research informed consent has been signed; 4. Patient agreed with the surgery plan and the disease meet the creterion of the breast-conserving surgery; 5. ECOG=2; 6. Maging detective mass after the neoadujvant treatment; 7. No radiation therapy history; 8. Be willing and capable to obey the rules of the research.

Exclusion criteria

Exclusion criteria: 1. Pathological diagnosis: Inflammatory Breast Cancer or invasive micropapillary carcinoma. 2. MRI undetctive mass. 3. Physician examination/ultrasound/mammography suggests the mass > 5cm. 4. Physician examination/ultrasound/mammography suggests the mass volume/breast volume > 50%. 5. Imaging examination suggests multicentre or multifocality disease, including diffuse calcifications on mammography. 6. Malignant tumor history in 5 years. 7. Suffering serious systemic disease. 8. Under other anticancer treatment or clinical research. 9. Distance metastasis confirmed or bilateral breast cancer. 10. Any mental disease which influence the understanding the informed consent. 11. Pregnancy. 12. Refusing breast-conserving surgery. 13. Reconstruct breast with implant or flap. 14. Unsuitable for breast-conserving surgery.

Design outcomes

Primary

Measure	Time frame
post-operation positive rate of cavity margins;	—

Secondary

Measure	Time frame
recut rate;tissue excision volume;difference value of tissue excision volume;surgery time;surgery cost;risk factors of positive margins;breast conservitive rate;cosmetic evaluation;adverse effects;Disease-free survival,;	—

Countries

China

Contacts

Public ContactNanyan Rao

Sun Yet-sen Memorial Hospital affiliated to Sun Yet-sen University

raonany@126.com+86 13539900010

Outcome results

None listed

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