Breast Conserving SurgeryNCT06593132
Single Port Endoscopic Breast Conserving Surgery
An observational study of Breast Conserving Surgery and Endoscopic Surgery, run by Ren,Yu at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Conserving Surgery, Endoscopic Surgery
- What is being tested?
- endoscopic breast conserving surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to Jun 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged 20-70 years who are eligible for breast-conserving surgery and are willing to undergo breast-conserving surgery.
Who may be able to join
- Breast cancer confirmed by pathology；
- Tumor <5 cm, TNM stage 0-II；
- Single Port Endoscopic or traditional open surgery; (4)20 to 70 years old female patients.
Who cannot join
- Bilateral breast cancer;
- Reconstruction after breast conserving surgery ;
- Basic information is not complete；
- Breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yu Ren, MD,PhD, 13700222161, renyyyyy@126.com
About this study
Official title: Prospective Clinical Study of Single Port Endoscopic Breast Conserving Surgery or Open Breast Conserving Surgery for Early Breast Cancer
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.
Read the detailed description
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
- Breast Conserving Surgery, Endoscopic Surgery
- Being tested
- endoscopic breast conserving surgery
- Keywords
- breast conserving surgery, single port endoscopic, early breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic breast conserving surgeryProcedure or surgery
Breast endoscopy technology completes complex surgical operations through small incisions, achieving aesthetically pleasing results while ensuring tumor safety.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: endoscopic breast conserving surgery | |
| 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. Receives: Procedure: endoscopic breast conserving surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six months after operation SURVIVAL EFFECTS
To compare the overall survival (OS) within 6 months after single-port endoscopic breast-conserving surgery and open breast-conserving surgery.
Measured: From enrollment to the end of 6 months after surgery
Secondary outcomes (3)
Intraoperative blood loss
To compare the total blood loss between single-port endoscopic breast-conserving surgery and open breast-conserving surgery.
Measured: From the beginning to the end of the operation
Postoperative drainage volume in the first three days after breast conserving surgery
The total drainage volume in the first three days after breast conserving surgery was compared between single-port endoscopic breast conserving surgery and open breast conserving surgery.
Measured: 3 days after surgery
Length of surgical incision
The total incision length was compared between single-port endoscopic breast-conserving surgery and open breast-conserving surgery.
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Conserving SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ren,Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ren,Yu, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593132
- Sponsor's protocol ID
- SPEBCS-2023
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Single Port Endoscopic Breast Conserving Surgery or Open Breast Conserving Surgery for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06593132
- Acronym / sponsor ID
- SPEBCS-2023
- Conditions
- Breast Conserving Surgery, Endoscopic Surgery
- Keywords
- breast conserving surgery, single port endoscopic, early breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ren,YuUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single port endoscopic breast conserving surgery | – | Procedure: endoscopic breast conserving surgeryEndoscopic 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. |
| open breast conserving surgery | – | Procedure: endoscopic breast conserving surgeryOn 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 20-70 years who are eligible for breast-conserving surgery and are willing to undergo breast-conserving surgery.
Key inclusion criteria (3 listed)
- Breast cancer confirmed by pathology；
- Tumor <5 cm, TNM stage 0-II；
- Single Port Endoscopic or traditional open surgery; (4)20 to 70 years old female patients.
Key exclusion criteria (4 listed)
- Bilateral breast cancer;
- Reconstruction after breast conserving surgery ;
- Basic information is not complete；
- Breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic breast conserving surgeryBreast endoscopy technology completes complex surgical operations through small incisions, achieving aesthetically pleasing results while ensuring tumor safety. | Procedure or surgery | open breast conserving surgery, single port endoscopic breast conserving surgery |
Primary outcome
Six months after operation SURVIVAL EFFECTS
Time frame: From enrollment to the end of 6 months after surgery
To compare the overall survival (OS) within 6 months after single-port endoscopic breast-conserving surgery and open breast-conserving surgery.
3 secondary outcomes
Intraoperative blood loss
Time frame: From the beginning to the end of the operation
Postoperative drainage volume in the first three days after breast conserving surgery
Time frame: 3 days after surgery
Length of surgical incision
Time frame: 1 week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Conserving Surgery and Endoscopic Surgery, run by Ren,Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoli Nan, bacheior (15114822852, 369075227@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six months after operation SURVIVAL EFFECTS (time frame: From enrollment to the end of 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.