Health TrialsbyHealthPanel

The Comparison Between M-E-BCS and C-O-BCS.

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorDu Zhenggui

About this trial

This study is a multicenter, open-label, randomized controlled trial. The study aims to evaluate differences in operative efficiency (e.g., operative time), economic effect, surgical safety (e.g., surgical complication rates), postoperative aesthetics (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores and Ueda scores), and oncological safety (e.g., margin status, no local recurrence survival) between patients undergoing M-E-BCS and patients undergoing C-O-BCS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

female patients aged 18-70 years (inclusive);

preoperative pathological examination confirmed it as invasive breast cancer or ductal carcinoma in situ;

both clinical and imaging examinations clearly indicated that the lesion was a single lesion confined within the gland, without invasion of the skin, subcutaneous tissue, pectoralis major muscle, or the nipple-areola complex;

tumors in the inner and outer quadrants (three classification method, as shown in Figure 2);

Disqualifiers

clinically or radiologically evaluated as multifocal or multicentric breast cancer, with diffuse suspicious calcification, long spiculated masses, extensive local resection unable to obtain sufficient negative margins or ideal shape;

persistent positive tumor margins, and resection cannot ensure negative margins after resection;

inflammatory breast cancer;

pregnant and lactating women;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minimal accessory-incision-assisted endoscopic breast-conserving surgery

    Procedure/Surgery

    A small incision was made in the concealed area of the armpit, and a endoscopic device was inserted. Under direct vision, the tumor was precisely removed and the lymph nodes in the armpit were cleared layer by layer. The incision was then sutured layer by layer, and a drainage tube was placed after the operation.

  • Conventional open breast-conserving surgery

    Procedure/Surgery

    Conventional open breast-conserving surgery is a surgical approach that aims to preserve the appearance and function of the breast as much as possible while ensuring the complete removal of the tumor. It is suitable for eligible patients with early-stage breast cancer and requires comprehensive postoperative treatment measures such as radiotherapy.

Treatment groups

1,366 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Local recurrence rates

The risk of local recurrence within five years.

Time frame
Postoperative 5 years

Secondary outcomes

1

Surgical efficiency

Total operative time (min) from skin incision to complete closure of incision, the operative time for axillary surgery and the operative time for breast surgery.

Time frame
Intraoperative
2

Economic effect

The total cost from the patient's admission to discharge, the surgery fee and the hospitalization fee (USD).

Time frame
1 month postoperative
3

Surgical safety

Surgical complication rates, major complication rates and minor complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis.

Time frame
Intraoperative, 3 months postoperative.
4

Aesthetic outcomes (BREAST-Q score)

The BREAST-Q scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores.

Time frame
Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Du Zhenggui

Lead sponsor

West China Hospital

Sponsor institution

West China Fourth Hospital

Collaborator

West China Second University Hospital

Collaborator

Fourth People's Hospital of Sichuan Province

Collaborator

Taiyuan Central Hospital of Shanxi Medical University

Collaborator

Chengdu Second people's hospital

Collaborator

Suzhou Municipal Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: