Single Port Endoscopic Breast Conserving Surgery

NCT ID: NCT06593132

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-06-30

Brief Summary

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The center plans to carry out a prospective clinical study of single hole total endoscopic breast conserving surgery for early breast cancer compared with open breast conserving surgery, to provide high-level evidence-based medical evidence for the development of endoscopic breast conserving surgery for early breast cancer.

Detailed Description

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Data show that breast cancer has surpassed lung cancer asthemost prevalent malignant tumor in the world, and traditional open surgery is highly invasive and has poor cosmetic results. This study investigates the results of endoscopic breast- conserving surgery(E-BCS) versus conventional breast-conserving surgery(C-BCS) in the treatment of patients with early-stage breast cancer and to compare the advantages and disadvantages of the two surgical procedures, so as to provide the best evidence for the rational choice of the procedure by both doctors and patients.

Conditions

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Breast Conserving Surgery Endoscopic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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single port endoscopic breast conserving surgery

Endoscopic breast conserving surgery, which uses breast endoscope for breast conserving surgery, can not only preserve the breast completely, but also meet the appearance needs of patients with breast preservation, and has more advantages than traditional surgery.

endoscopic breast conserving surgery

Intervention Type PROCEDURE

Breast endoscopy technology completes complex surgical operations through small incisions, achieving aesthetically pleasing results while ensuring tumor safety.

open breast conserving surgery

On the surface of the breast tumor centered, is apart from the 2 cm do arc, radial incision tumor, tags in the cut edge around the joints and removing tissue inspection, to ensure the cut edge negative.

endoscopic breast conserving surgery

Intervention Type PROCEDURE

Breast endoscopy technology completes complex surgical operations through small incisions, achieving aesthetically pleasing results while ensuring tumor safety.

Interventions

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endoscopic breast conserving surgery

Breast endoscopy technology completes complex surgical operations through small incisions, achieving aesthetically pleasing results while ensuring tumor safety.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Breast cancer confirmed by pathology;
2. Tumor \<5 cm, TNM stage 0-II;
3. Single Port Endoscopic or traditional open surgery; (4)20 to 70 years old female patients.

Exclusion Criteria

1. Bilateral breast cancer;
2. Reconstruction after breast conserving surgery ;
3. Basic information is not complete;
4. Breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ren,Yu

OTHER

Sponsor Role lead

Responsible Party

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Ren,Yu

chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhaoli Nan, bacheior

Role: CONTACT

15114822852

Facility Contacts

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Yu Ren, MD,PhD

Role: primary

13700222161

Other Identifiers

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SPEBCS-2023

Identifier Type: -

Identifier Source: org_study_id

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