Active — Not RecruitingNot Applicable

The Effectiveness of Lymphatic Bypass Supermicrosurgery

Indonesia140 participantsStarted 2022-10-06

Plain-language summary

This study evaluate the effectiveness of lymphatic bypass supermicrosurgery (LBS) and axillary lymph node dissection (ALND) compare to ALND alone to prevent breast cancer treatment-related lymphedema (BCRL).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Breast cancer patient aged \>18 years old * Breast cancer patient with clinically ALNs metastases (cN1 or cN2). * Breast cancer patient with no clinical metastasis and tumor size ≥5cm or no sentinel lymph node biopsy facility in the hospital. * Any breast cancer patients that receive neoadjuvant systemic therapy. Exclusion Criteria: * Stage IV breast cancer patients who do not show clinical and radiological improvement after primary systemic therapy. * Breast cancer patients with previous surgeries such as mastectomy, axillary lymph node biopsy, sentinel lymph node biopsy (SLNB), and ALND. * Breast cancer patients with prior breast, chest wall, axillary, or neck radiotherapy. * Breast cancer patients with preoperative lymphatic system abnormality detected by ICG lymphography. * Breast cancer patients with iodine allergy, asthma, decreased kidney function, pregnancy, and lactation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative incidence of BCRL

Timeframe: 1 year

Trial details

NCT IDNCT05682885

SponsorDharmais National Cancer Center Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-10-31

View on ClinicalTrials.gov More Breast Cancer Related Lymphedema trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.