Clinical trial · Interventional
Lymphaticovenous Anastomosis as Treatment for Lymphedema
Lymphaticovenous Anastomosis as a Surgical Treatment for Breast Cancer-Related Lymphedema
NCT05441943CI-TRIAL-00074685active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The primary aim of this study is to investigate and test whether the use of combined indocyanine green (ICG) lymphography and ultra high frequency ultrasonography can correctly identify lymphatic vessels and venoles in close proximity to each other, for identification prior to lymphovenous anastomosis (LVA) surgery.
Conditions
Conditions (22)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomose | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Lymphedema | — | UNRESOLVED | — |
| Breast Diseases | — | UNRESOLVED | — |
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Iatrogenic Lymphedema | — | UNRESOLVED | — |
| Lymphatic Diseases | — | UNRESOLVED | — |
| Lymphedema | — | UNRESOLVED | — |
| Lymphedema Arm | — | UNRESOLVED | — |
| Lymphedema, Breast Cancer | — | UNRESOLVED | — |
| Lymphedema of Upper Limb | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphovenous anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lymphovenous anastomosis surgery
- description
- Lymphovenous anastomosis surgery with pre-operative planning using ICG lymphography and ultra high frequency ultrasound.
- interventionNames
- Procedure: Lymphovenous anastomosis
Primary outcomes (2)
- measure
- Number of vessels planned for surgery surgery
- timeFrame
- Preoperative
- description
- The number of mapped lymphatics vessels and venoles.
- measure
- Number of vessels found during surgery
- timeFrame
- Perioprative
- description
- The number of vessels found during surgery. This number will be compared to the number of vessels planned for surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Iatrogenic lymphedema following treatment for breast cancer in upper extremity * Possible to obtain informed consent * Age\>18 Exclusion Criteria: * Duration of disease over 24 months * Smoker * Untreated or uncontrolled primary cancer * No applicable lymphatic vessels identified, using ICG lymphangiography * No applicable venous vessels identified using ultra high frequency ultrasound
References
Publications (32)
- BACKGROUNDArmer JM, Ballman KV, McCall L, Armer NC, Sun Y, Udmuangpia T, Hunt KK, Mittendorf EA, Byrd DR, Julian TB, Boughey JC. Lymphedema symptoms and limb measurement changes in breast cancer survivors treated with neoadjuvant chemotherapy and axillary dissection: results of American College of Surgeons Oncology Group (ACOSOG) Z1071 (Alliance) substudy. Support Care Cancer. 2019 Feb;27(2):495-503. doi: 10.1007/s00520-018-4334-7. Epub 2018 Jul 6. PMID 29980907
- BACKGROUNDDiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27. PMID 23540561
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDMaajani K, Jalali A, Alipour S, Khodadost M, Tohidinik HR, Yazdani K. The Global and Regional Survival Rate of Women With Breast Cancer: A Systematic Review and Meta-analysis. Clin Breast Cancer. 2019 Jun;19(3):165-177. doi: 10.1016/j.clbc.2019.01.006. Epub 2019 Jan 29. PMID 30952546
- BACKGROUNDMarkkula SP, Leung N, Allen VB, Furniss D. Surgical interventions for the prevention or treatment of lymphoedema after breast cancer treatment. Cochrane Database Syst Rev. 2019 Feb 19;2(2):CD011433. doi: 10.1002/14651858.CD011433.pub2. PMID 30779124
- BACKGROUNDDrobot A, Bez M, Abu Shakra I, Merei F, Khatib K, Bickel A, Ganam S, Bogouslavski G, Karra N, Mahran B, Kassis W, Kogan L, Drobot D, Weiss M, Koshima I, Kakiashvili E. Microsurgery for management of primary and secondary lymphedema. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):226-233.e1. doi: 10.1016/j.jvsv.2020.04.025. Epub 2020 May 21.