Clinical trial · Interventional
Prophylactic LYMphatic Reconstruction (LYMbR) to Prevent Lymphedema After Node Dissection for Cutaneous Malignancies
Prophylactic LYMphatic Reconstruction (LYMbR) to Prevent Lymphedema
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Lymphedema following lymph node dissection is a chronic condition that can limit physical, occupational, and social participation, impact self-image, and result in financial burden. Studies have reported lymphedema incidence rates of 39% to 73% following node dissection. Lymphaticovenous anastomosis (LVA) has been previously used to treat established lymphedema. More recently, with imaging capabilities guided by blue dye and indocyanine green dye, the possibility of prophylactic LVA has become feasible. A 2018 systematic review of 12 studies utilizing prophylactic LVA during lymphadenectomy indicated a 2/3 reduction in the risk of lymphedema. The literature yet lacks any phase III studies with stringent controls and long term follow-up. Objectives: To assess (primary endpoint) the impact of prophylactic LVA on presence or absence of lymphedema post axillary or groin lymphadenectomy and participant quality of life. To assess (secondary endpoint) the incidence of complications related to nodal dissection. Methods: This is a phase III RCT, block randomized for upper and lower extremities, recruiting adult patients planned for an axillary or groin node dissection as a result of cutaneous malignancy. Analysis of rates of lymphedema and quality of life reports will be done. Significance: Lymphedema is a feared outcome of surgical cancer care. Its impact on patients' daily lives is profound. A reduction of incidence of this debilitating condition by 2/3 would have significant impact on numerous lives and could also reduce the health system resources needed for its management.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema of Limb | — | UNRESOLVED | — |
| Malignant Skin Neoplasm | Malignant Skin Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic lymphaticonvenous anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prophylactic lymphaticovenous anastomosis
- description
- Intervention participants will undergo prophylactic lymphaticovenous anastomosis as an addendum to axillary or ilioinguinal lymphadenectomy for treatment of cutaneous malignancy.
- interventionNames
- Procedure: Prophylactic lymphaticonvenous anastomosis
- type
- NO_INTERVENTION
- label
- Lymphadenectomy without lymphaticovenous anastomosis
- description
- Control participants will undergo axillary or ilioinguinal lymphadenectomy without lymphaticovenous anastomosis for treatment of cutaneous malignancy .
Primary outcomes (2)
- measure
- Presence or absence of lymphedema at 24 months post axillary or groin lymphadenectomy as assessed by limb volume over time.
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult persons (\>18 years of age) undergoing axilla or groin lymphadenectomy as part of cutaneous malignancy management. Exclusion Criteria: * Patients receiving a sentinel lymph node biopsy alone * Patients with untreated in-transit disease on the upper or lower extremities * Patients with established preoperative lymphedema * Patients with post-thrombotic syndrome * Pregnant patients * Patients with a previous history of radiation therapy to the affected nodal basin or extremity
References
Publications (18)
- BACKGROUNDCakmakoglu C, Kwiecien GJ, Schwarz GS, Gastman B. Lymphaticovenous Bypass for Immediate Lymphatic Reconstruction in Locoregional Advanced Melanoma Patients. J Reconstr Microsurg. 2020 May;36(4):247-252. doi: 10.1055/s-0039-3401829. Epub 2019 Dec 31. PMID 31891946
- BACKGROUNDRockson SG. Causes and consequences of lymphatic disease. Ann N Y Acad Sci. 2010 Oct;1207 Suppl 1:E2-6. doi: 10.1111/j.1749-6632.2010.05804.x. PMID 20961302
- BACKGROUNDCampanholi LL, Duprat JP, Fregnani JHTG. Incidence of le due to treating cutaneous melanoma. J Lymphoedema. 2011; 16(1): 30-34.
- BACKGROUNDPaskett ED, Dean JA, Oliveri JM, Harrop JP. Cancer-related lymphedema risk factors, diagnosis, treatment, and impact: a review. J Clin Oncol. 2012 Oct 20;30(30):3726-33. doi: 10.1200/JCO.2012.41.8574. Epub 2012 Sep 24. PMID 23008299
- BACKGROUNDLoprinzi PD, Cardinal BJ, Winters-Stone K, Smit E, Loprinzi CL. Physical activity and the risk of breast cancer recurrence: a literature review. Oncol Nurs Forum. 2012 May 1;39(3):269-74. doi: 10.1188/12.ONF.269-274. PMID 22543385
- BACKGROUNDBaibergenova A, Drucker AM, Shear NH. Hospitalizations for cellulitis in Canada: a database study. J Cutan Med Surg. 2014 Jan-Feb;18(1):33-7. doi: 10.2310/7750.2013.13075. PMID 24377471
- BACKGROUNDTiwari P, Coriddi M, Salani R, Povoski SP. Breast and gynecologic cancer-related extremity lymphedema: a review of diagnostic modalities and management options. World J Surg Oncol. 2013 Sep 22;11:237. doi: 10.1186/1477-7819-11-237. PMID 24053624
- BACKGROUNDDunberger G, Lindquist H, Waldenstrom AC, Nyberg T, Steineck G, Avall-Lundqvist E. Lower limb lymphedema in gynecological cancer survivors--effect on daily life functioning. Support Care Cancer. 2013 Nov;21(11):3063-70. doi: 10.1007/s00520-013-1879-3. Epub 2013 Jun 29.