Microvascular Breast Reconstruction With Lymph Node Transfer
Primary Purpose
Lymphedema, Lymphedema of Upper Arm, Mastectomy; Lymphedema
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microvascular Breast Reconstruction with Vascularized Lymph Node Transfer
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema focused on measuring VLNT, breast reconstruction, postmastectomy lymphedema, vascularized lymph node transfer, lymphedema surgery, microsurgery
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cases
Arm 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.
Outcomes
Primary Outcome Measures
Change in upper limb volume
Assessment of volume reduction by measuring limb circumference of affected and non affected upper limbs at fixed points from shoulder, elbow & wrist joints
Change in lymphatic flow
lymphoscintigraphy will be used to trace radiological signs of Lymphatic flow improvement such as reduced dermal backflow, appearance of new lymph drainage channels, reduced stasis and increased rate of radiolabeled tracer clearance
Secondary Outcome Measures
Quality of life measure for limb lymphedema (LYMQOL)
Quality of life parameters will be measured using LYMQOL survey. Questions in the survey cover four areas: symptoms, body image/appearance, function and mood. Answers are scored 1-4 (less severe to severe)
Quality of life measure for breast
patient quality of life will be evaluated using Breast-Q "Reconstruction Module", which includes different modules for assessment of quality of life and patient satisfaction after breast reconstruction. These scales are designed to be administered pre-operatively and assess patient expectations for the process and outcome of surgery. The expectations scales compliment the satisfaction and quality-of life domains of the postoperative reconstruction module. Multi-item and categorical scale structures are used. Five scales provide a 0-100 score. A higher score means better quality of life and more satisfaction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04246034
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
surgery considered elective and cant be performed within corona restrictions
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Lymphedema of Upper Arm, Mastectomy; Lymphedema
Keywords
VLNT, breast reconstruction, postmastectomy lymphedema, vascularized lymph node transfer, lymphedema surgery, microsurgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cases
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Microvascular Breast Reconstruction with Vascularized Lymph Node Transfer
Intervention Description
simultaneous free abdominal flaps with VLNT from groin are transferred on a single pedicle for breast reconstruction and postmastectomy lymphedema
Primary Outcome Measure Information:
Title
Change in upper limb volume
Description
Assessment of volume reduction by measuring limb circumference of affected and non affected upper limbs at fixed points from shoulder, elbow & wrist joints
Time Frame
6-12 months
Title
Change in lymphatic flow
Description
lymphoscintigraphy will be used to trace radiological signs of Lymphatic flow improvement such as reduced dermal backflow, appearance of new lymph drainage channels, reduced stasis and increased rate of radiolabeled tracer clearance
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Quality of life measure for limb lymphedema (LYMQOL)
Description
Quality of life parameters will be measured using LYMQOL survey. Questions in the survey cover four areas: symptoms, body image/appearance, function and mood. Answers are scored 1-4 (less severe to severe)
Time Frame
6-12 months
Title
Quality of life measure for breast
Description
patient quality of life will be evaluated using Breast-Q "Reconstruction Module", which includes different modules for assessment of quality of life and patient satisfaction after breast reconstruction. These scales are designed to be administered pre-operatively and assess patient expectations for the process and outcome of surgery. The expectations scales compliment the satisfaction and quality-of life domains of the postoperative reconstruction module. Multi-item and categorical scale structures are used. Five scales provide a 0-100 score. A higher score means better quality of life and more satisfaction.
Time Frame
6-12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
as the scope of study is breast cancer, participant should be of female gender
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youssef S Hassan, MD
Organizational Affiliation
Assiut University Hospitals - Plastic Surgery Dept.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Haitham Khalil, MD, FRCS
Organizational Affiliation
Divison of Plastic and Reconstructive Surgery (University Hospitals Birmingham)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Awny M Asklany, MD
Organizational Affiliation
Assiut University Hospitals - Plastic Surgery Dept.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22233832
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.
Results Reference
background
PubMed Identifier
23540561
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.
Results Reference
background
PubMed Identifier
28009597
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.
Results Reference
background
PubMed Identifier
29908550
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.
Results Reference
background
PubMed Identifier
29572824
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.
Results Reference
background
PubMed Identifier
28594742
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.
Results Reference
background
PubMed Identifier
29636652
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.
Results Reference
background
PubMed Identifier
25623599
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.
Results Reference
background
Learn more about this trial
Microvascular Breast Reconstruction With Lymph Node Transfer
We'll reach out to this number within 24 hrs