Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New endoscopic breast reconstruction could change surgery for cancer patients

NCT ID NCT06817954

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will compare two surgical approaches for breast cancer patients who need a mastectomy (breast removal) and immediate reconstruction. One group will have standard surgery, while the other will use a newer, endoscopic-assisted technique that may involve smaller incisions. Researchers will track 800 women over time to see which method leads to fewer cancer recurrences and complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
endoscopic-assisted mastectomy and immediate breast reconstruction (procedure)
What this could lead to
If successful, this could show that endoscopic-assisted surgery is a safe and effective option for breast reconstruction after mastectomy, potentially reducing scarring and recovery time.
What could go wrong
This is an early-stage exploratory study, so results may not confirm superiority over standard surgery. Risks include complications like infection, bleeding, or recurrence, and the technique may not suit all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female patients, aged 18-75 years old; The pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal patients; 2. Patients with the diagnosed breast cancer confirmed by core needle biopsy and unilateral operation was performed; Breast cancer patients with tumor node metastasis stage 0-III according to the 8th edition of the American Joint Commission on Cancer; Preoperative clinical examination or imaging evaluation shows that the distance between the tumor and the Nipple Areolar Complex (NAC) is more than 1cm. The tumor has a diameter of 2-3 cm and can be located in any quadrant or reduced to 3 cm through preoperative neoadjuvant chemotherapy. The distance between the lesion and the skin should be at least 8-10 mm; 3. There is no clinical or imaging evidence to prove that the tumor has invaded the skin, chest wall, or nipple areola complex; 4. There are indications for breast preservation, but the patient has a strong desire for reconstruction and is unwilling to undergo breast preservation surgery; 5. Preventive mastectomy (BRCA1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups); 6. Preoperative clinical manifestations and imaging data showed no distant metastasis; 7. No history of breast cancer or other serious underlying diseases in the past; 8. Karnofsky performance status score ≥ 70; 9. Eastern Cooperative Oncology Group score ≤ 2 ; 10. The surgical procedure includes endoscopic-assisted/conventional mastectomy, sentinel lymph node biopsy/axillary lymph node dissection and immediate breast reconstruction; 11. Participants are able to understand the research process, voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up; 12. No swallowing difficulties; No shoulder joint movement disorders; 13. Complete clinical data. Exclusion Criteria: 1. Male breast cancer or inflammatory breast cancer; 2. Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC; 3. The clinical data is basically incomplete; 4. Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital; 5. Bilateral breast cancer surgery; 6. Other surgical methods; 7. Preoperative distant metastasis or supraclavicular lymph node dissection; 8. Complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years; 9. The serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state; 10. Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital with Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210009, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.