Clinical trial · Interventional
Microvascular Breast Reconstruction With Lymph Node Transfer
Evaluation of Outcomes of Microvascular Breast Reconstruction With Lymph Node Transfer for Postmastectomy Lymphedema Patients
NCT04246034CI-TRIAL-00048564withdrawnN/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): surgery considered elective and cant be performed within corona restrictions
Summary
Brief summary (as posted)
this study aims to evaluate the outcomes of simultaneous free abdominal flap \& vascularized lymph node transfer for both breast reconstruction and postmastectomy lymphedema
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 |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
| Lymphedema of Upper Arm | — | UNRESOLVED | — |
| Mastectomy; Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microvascular Breast Reconstruction with Vascularized Lymph Node Transfer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cases
- description
- As described by Saaristo et al. in 2012, the surgical technique starts with wide axillary scar removal, followed by elevation of contralateral dual flap which includes DIEP/MS-TRAM with attached groin lymph nodes and fat, then the anastomosis is preferably done to internal mammary vessels.
- interventionNames
- Procedure: Microvascular Breast Reconstruction with Vascularized Lymph Node Transfer
Primary outcomes (2)
- measure
- Change in upper limb volume
- timeFrame
- 6-12 months
- description
- Assessment of volume reduction by measuring limb circumference of affected and non affected upper limbs at fixed points from shoulder, elbow \& wrist joints
- measure
- Change in lymphatic flow
- timeFrame
- 6-12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients of 20-65 years old * Patients seeking autologous breast reconstruction and complain of clinically diagnosed arm lymphedema * Deficient lymphatic drainage on lymphoscintigraphy * Stage II and III Lymphedema * no active cellulitis * more than 12 months of follow-up Exclusion Criteria: * Females \< 20 or \>65 years old * distant metastasis * brachial plexus neuritis. * Patients with unhealthy and obstructed recipient veins or congestive heart disease with limited venous return may not be a suitable candidate for the procedure.
References
Publications (8)
- BACKGROUNDSaaristo AM, Niemi TS, Viitanen TP, Tervala TV, Hartiala P, Suominen EA. Microvascular breast reconstruction and lymph node transfer for postmastectomy lymphedema patients. Ann Surg. 2012 Mar;255(3):468-73. doi: 10.1097/SLA.0b013e3182426757. PMID 22233832
- 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
- BACKGROUNDSmile TD, Tendulkar R, Schwarz G, Arthur D, Grobmyer S, Valente S, Vicini F, Shah C. A Review of Treatment for Breast Cancer-Related Lymphedema: Paradigms for Clinical Practice. Am J Clin Oncol. 2018 Feb;41(2):178-190. doi: 10.1097/COC.0000000000000355. PMID 28009597
- BACKGROUNDExecutive Committee. The Diagnosis and Treatment of Peripheral Lymphedema: 2016 Consensus Document of the International Society of Lymphology. Lymphology. 2016 Dec;49(4):170-84. PMID 29908550
- BACKGROUNDPappalardo M, Patel K, Cheng MH. Vascularized lymph node transfer for treatment of extremity lymphedema: An overview of current controversies regarding donor sites, recipient sites and outcomes. J Surg Oncol. 2018 Jun;117(7):1420-1431. doi: 10.1002/jso.25034. Epub 2018 Mar 24. PMID 29572824
- BACKGROUNDEngel H, Lin CY, Huang JJ, Cheng MH. Outcomes of Lymphedema Microsurgery for Breast Cancer-related Lymphedema With or Without Microvascular Breast Reconstruction. Ann Surg. 2018 Dec;268(6):1076-1083. doi: 10.1097/SLA.0000000000002322. PMID 28594742
- BACKGROUNDChang EI, Masia J, Smith ML. Combining Autologous Breast Reconstruction and Vascularized Lymph Node Transfer. Semin Plast Surg. 2018 Feb;32(1):36-41. doi: 10.1055/s-0038-1632402. Epub 2018 Apr 9.