Lymphovenous bypass to prevent arm lymphedema after axillary lymph node removal
Official title: Effectiveness of Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
Run by Dharmais National Cancer Center Hospital · NCT07233863 · Data updated 2026-11-12
This study will try adding a lymphovenous bypass during axillary lymph node dissection to see if it prevents or slows arm lymphedema in adults with breast cancer compared with physiotherapy alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 136 (estimated) |
| Sponsor | Dharmais National Cancer Center Hospital Government |
| Locations | 1 site (Jakarta, Jakarta Special Capital Region) |
| Status | Recruiting |
| Started | March 18, 2024 |
| Main results expected | March 21, 2027 |
| Study ends | March 21, 2028 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07233863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with breast cancer who have undergone axillary lymph node dissection, have stage 0–I lymphedema, have not had prior lymphedema physiotherapy, have an ECOG score > 1, and can attend 24-month follow-up are the intended participants.
✕Probably not a fit
Patients with dermal backflow before axillary dissection, more advanced lymphedema, iodine allergy, severe asthma, decreased kidney function, pregnancy or breastfeeding, or inability to complete follow-up are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants receive either a lymphovenous bypass (LVB) at the time of axillary lymph node dissection or physiotherapy alone as the comparator. LVB is performed using super-microsurgery with intima-to-intima coaptation to connect an afferent lymphatic vessel to a recipient vein. Progression of lymphedema is monitored using the upper extremity lymphedema (UEL) index and indocyanine green (ICG) lymphography. Follow-up is planned for 24 months and patients with relevant contraindications are excluded.
Why it matters
Potential benefit: If successful, the procedure could reduce the development or severity of arm lymphedema and improve arm function and quality of life.
How similar studies have gone: Similar super-microsurgical lymphovenous bypass procedures have shown promising results in small and nonrandomized studies for early-stage lymphedema, but larger randomized data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Breast cancer patients aged ≥ 18 years with an ECOG score \> 1 * Breast cancer patients with post-axillary lymph node dissection diagnosed with stage 0 and I lymphedema. * Those who have never undergone lymphedema physiotherapy. Exclusion Criteria: * Patients with dermal backflow before axillary lymph node dissection (ALND). * Patients with breast cancer lymphedema who are unable to undergo a 24-month follow-up at Dharmais Cancer Hospital. * Patients with iodine allergy, severe asthma, decreased kidney function, pregnancy, or breastfeeding.
Where it's running
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Dharmais National Cancer Center
Jakarta, Jakarta Special Capital Region, Indonesia Recruiting
Study contacts
- Principal investigator: Bayu Brahma, MD, PhD — Dharmais Cancer Hospital - National Cancer Center
- Study coordinator: Adhitya B Perdana, MEpi
- Email: adhityabayu@dharmais.co.id
- Phone: +62 85692445029
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.