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Comparison the safety and aesthetic effects of a novel endoscopic-assisted breast-conserving surgery (SRRSHzb-EABCS) with conventional breast-conserving surgery

Comparison the safety and aesthetic effects of a novel endoscopic-assisted breast-conserving surgery (SRRSHzb-EABCS) with conventional breast-conserving surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068807
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Breast Cancer

Interventions

Expenrimental group:Receive endoscopy assisted breast-conserving surgery (EABCS).
Control group:Receive conventional breast-conserving surgery.

Sponsors

Affiliated Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1: Female; 2: Aged 18 to 70 years old; 3: Breast cancer confirmed by preoperative pathology; 4: The patient volunteers to participate in the clinical trial and sign informed consents; 5: The patient has a desire to conserve breast; 6: Stage I or II invasive breast cancer: the tumor size belongs to T1 and T2 stages and the proportion of tumor volume to breast gland volume is appropriate, and the ideal breast shape can be obtained after surgery; 7: Stage III Breast cancer (except inflammatory breast cancer ) patients, who meet the breast-conserving conditions after preoperative neoadjuvant treatment; 8: The patients can guarantee acceptance of the radiological therapy postoperatively and sign informed consents.

Exclusion criteria

Exclusion criteria: 1: Pregnant or lactating women; 2: Previous radiotherapy history; 3: Patients with a history of vital organs dysfunction; 4: Patients with a history of other malignant tumors; 5: Sufficient negative margin or ideal shape cannot be obtained by extensive local resection; 6: Diffuse suspicious calcification foci; 7: Multifocal or multicentric breast cancer; 8: Dimple sign was positive; 9: Lesions invade the skin or pectoralis major muscle; 10: Patients do not accept randomized processes; 11: Vulnerable groups.

Design outcomes

Primary

MeasureTime frame
positive margins;—

Secondary

MeasureTime frame
aesthetic outcome;ratio of complications;local recurrent rate;Disease-Free Survival (DFS);Overall Survival (OS);—

Countries

China

Contacts

Public ContactLinbo Wang

Department of Surgical Oncology, Affiliated Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

linbowang@zju.edu.cn+86 135 8870 6949

Outcome results

None listed

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