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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Withdrawn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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    January 18, 2020
    Last Updated
    November 26, 2020
    Sponsor
    Assiut University
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    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

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    Microvascular Breast Reconstruction With Lymph Node Transfer

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