Clinical trial NCT04246034: Microvascular Breast Reconstruction With Lymph Node Transfer
Official title: Evaluation of Outcomes of Microvascular Breast Reconstruction With Lymph Node Transfer for Postmastectomy Lymphedema Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lymphedema
Lymphedema of Upper Arm
Mastectomy; Lymphedema
Keywords: VLNT
breast reconstruction
postmastectomy lymphedema
vascularized lymph node transfer
lymphedema surgery
microsurgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: this study aims to evaluate the outcomes of simultaneous free abdominal flap \& vascularized lymph node transfer for both breast reconstruction and postmastectomy lymphedema

Detailed description: Microvascular breast reconstruction allows for the transfer of donor tissue that is an excellent match for native breast tissue, both in terms of the subcutaneous tissue that reconstitutes the breast mound and the simultaneous transfer of skin. In addition, it offers a wide range of options for women who may have been previously not considered for autologous tissue transfer. From the these various options, the deep inferior epigastric artery perforator (DIEP) flap and the muscle-sparing transverse rectus abdominis myocutaneous (MS-TRAM) flap are the most recognized free flap options for breast reconstruction today

Besides the needs for breast reconstruction after mastectomy \& axillary lymph node dissection, upper limb lymphedema is also a major concern for postmastectomy patients which is estimated to occur in 21.4% of women treated for breast cancer. It represents a diagnostic and therapeutic challenge for clinicians due to the heterogeneity in presentation as well as multitude of treatment options available. In addition, with a lack of evidence-based guidelines

. According to the International Society of Lymphology Consensus, the clinical staging of lymphedema includes; Stage 0 (Subclinical) when lymphatic vessels have been injured but have no measurable swelling or edema. Stage I lymphedema occurs with the onset of measurable swelling and pitting of the skin which can be regressed on conservative treatments. Stage II considered when there is edema partially regressing with treatments and negative pitting test. Stage III encompasses lymphostatic elephantiasis with trophic skin changes and recurrent infections.

In recent years, lymphatic microsurgery procedures have increased in popularity, bringing in a new wave of physiologic surgical options for the management of lymphedema. The two most common microsurgical options include lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT). Each treatment option has the potential to bypass areas of damaged lymphatics by rerouting the lymph into the venous system or by replacing the lost lymph nodes and, or lymphatic ducts.

Recent studies have evaluated the positive effects of VLNT in the setting of lymphedema and have shown significantly better results for the patients in which the native lymphatic ducts are no longer available when compared to conservative treatments or LVA.

There are several potential donor sites that can be used for the VLNT, and currently, there is no clear consensus as to which lymph node basin represents the ideal donor site. But the most popular lymph nodes have been the supraclavicular nodes, the submental nodes, the lateral thoracic nodes, the inguinal nodes, the omentum, and more recently the mesenteric lymph nodes. However, in patients suffering from post-mastectomy lymphedema, the inguinal nodes can be transferred at the time of autologous breast reconstruction, coupling the inguinal nodes to (DIEP) flap or (MS-TRAM) flap to reconstruct the patient's breast while simultaneously addressing the patient's lymphedema in one operation .

Advantages of simultaneous breast reconstruction \& VLNT include the extensive scar removal and release in the axilla, which is critical to optimizing the recipient bed for the VLNT and the relatively hidden scar in axilla. Although a promising technique, it remains investigational and requires larger studies with longer follow-up to validate its true utility. Of primary concern is monitoring for the longevity of the results and making certain that additional donor site morbidity is avoided.

To the best of the investigator's knowledge, few studies were conducted on the use of free abdominal free flaps in conjunction with VLNT from the groin for simultaneous lymphedema treatment \& breast reconstruction. But these studies were limited by small sample sizes.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in upper limb volume
timeFrame: 6-12 months
measure: Change in lymphatic flow
timeFrame: 6-12 months
Secondary outcomes:
measure: Quality of life measure for limb lymphedema (LYMQOL)
timeFrame: 6-12 months
measure: Quality of life measure for breast
timeFrame: 6-12 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University Hospitals - Plastic Surgery Dept.
name: Youssef S Hassan, MD
role: STUDY_CHAIR
affiliation: Divison of Plastic and Reconstructive Surgery (University Hospitals Birmingham)
name: Haitham Khalil, MD, FRCS
role: STUDY_DIRECTOR
affiliation: Assiut University Hospitals - Plastic Surgery Dept.
name: Awny M Asklany, MD
role: STUDY_DIRECTOR
References:
citation: Saaristo 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.
citation: DiSipio 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.
citation: Smile 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.
citation: Executive Committee. The Diagnosis and Treatment of Peripheral Lymphedema: 2016 Consensus Document of the International Society of Lymphology. Lymphology. 2016 Dec;49(4):170-84.
citation: Pappalardo 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.
citation: Engel 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.
citation: Chang 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.
citation: Nguyen AT, Chang EI, Suami H, Chang DW. An algorithmic approach to simultaneous vascularized lymph node transfer with microvascular breast reconstruction. Ann Surg Oncol. 2015 Sep;22(9):2919-24. doi: 10.1245/s10434-015-4408-4. Epub 2015 Jan 27.