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A multicenter randomized controlled trial of endoscopic breast conserving surgery versus traditional breast conserving surgery for breast cancer (ESTRACS study)

A multicenter randomized controlled trial of endoscopic breast conserving surgery versus traditional breast conserving surgery for breast cancer (ESTRACS study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061907
Enrollment
Unknown
Registered
2022-07-10
Start date
2022-07-15
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Breast cancer

Interventions

Experimental group:Endoscopic breast conserving surgery
Control group:Traditional breast conserving surgery

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Preoperative pathological examination confirmed stage I or II invasive breast cancer or ductal carcinoma in situ; 2. The tumor size belongs to T1 and T2 stages (if the patient has received neoadjuvant therapy, the stage after neoadjuvant therapy shall prevail), the ratio of tumor volume to breast gland volume is appropriate, and ideal breast shape can be obtained after surgery; 3. Clinical and imaging examinations are clearly a single lesion confined to the gland, without invading the skin, subcutaneous tissue, pectoralis major and nipple-areolar complex; 4. The patient has a clear willingness to breastfeed, and postoperative radiotherapy can be standardized.

Exclusion criteria

Exclusion criteria: 1. The maximum diameter of the tumor before or after neoadjuvant therapy is >= 5 cm; 2. Breast cancer in the central region and the distance from the nipple <= 2 cm; 3. Tumor resection margins are continuously positive, and re-excision cannot guarantee negative resection margins; 4. Inflammatory breast cancer; 5. There used to be scars on the surface of the breast skin; 6. The patient is a carrier of BRCA1 and BRCA2 gene mutations.

Design outcomes

Primary

MeasureTime frame
Cosmetic effect;Breast satisfaction;Psychosocial well-being;Sexual well-being;Chest well-being;Short-term safety;Long-term safety;Economic cost of health;

Countries

China

Contacts

Public ContactZhenggui Du

West China Hospital, Sichuan University

docduzg@163.com+86 18980605774

Outcome results

None listed

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