Clinical trial · Interventional
Preventing Lymphedema in Axillary Lymph Node Dissection
Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass
NCT03428581CI-TRIAL-00103950terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual; diminished funding
Summary
Brief summary (as posted)
The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALND | Procedure | — | UNRESOLVED |
| ALND with ARM +/- LVB | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ALND with ARM +/- LVB
- description
- Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.
- interventionNames
- Procedure: ALND with ARM +/- LVB
- type
- ACTIVE_COMPARATOR
- label
- ALND without ARM +/- LVB
- description
- Axillary Lymph Node Dissection (ALND)
- interventionNames
- Procedure: ALND
Primary outcomes (2)
- measure
- Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Patients scheduled to undergo an axillary lymph node dissection * Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings * English speaking Exclusion Criteria * Prior ipsilateral axillary lymph node dissection * Prior ipsilateral axillary radiation * Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement * Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema. * Pregnant patients cannot participate in the substudy
References
Publications (0)
Data not yet available
No reference posted for this study.