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Microvascular Breast Reconstruction With Lymph Node Transfer

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ClinicalTrials.gov Identifier: NCT04246034
Recruitment Status : Withdrawn (surgery considered elective and cant be performed within corona restrictions)
First Posted : January 29, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed ElSayed Sharaf Ahmed, Assiut University

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

Condition or disease Intervention/treatment Phase
Lymphedema Lymphedema of Upper Arm Mastectomy; Lymphedema Procedure: Microvascular Breast Reconstruction with Vascularized Lymph Node Transfer Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Outcomes of Microvascular Breast Reconstruction With Lymph Node Transfer for Postmastectomy Lymphedema Patients
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cases
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.
Procedure: Microvascular Breast Reconstruction with Vascularized Lymph Node Transfer
simultaneous free abdominal flaps with VLNT from groin are transferred on a single pedicle for breast reconstruction and postmastectomy lymphedema




Primary Outcome Measures :
  1. Change in upper limb volume [ Time Frame: 6-12 months ]
    Assessment of volume reduction by measuring limb circumference of affected and non affected upper limbs at fixed points from shoulder, elbow & wrist joints

  2. Change in lymphatic flow [ Time Frame: 6-12 months ]
    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 :
  1. Quality of life measure for limb lymphedema (LYMQOL) [ Time Frame: 6-12 months ]
    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)

  2. Quality of life measure for breast [ Time Frame: 6-12 months ]
    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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   as the scope of study is breast cancer, participant should be of female gender
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246034


Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Youssef S Hassan, MD Assiut University Hospitals - Plastic Surgery Dept.
Study Director: Haitham Khalil, MD, FRCS Divison of Plastic and Reconstructive Surgery (University Hospitals Birmingham)
Study Director: Awny M Asklany, MD Assiut University Hospitals - Plastic Surgery Dept.
Publications:

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Responsible Party: Ahmed ElSayed Sharaf Ahmed, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04246034    
Other Study ID Numbers: VLNT for lymphedema
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed ElSayed Sharaf Ahmed, Assiut University:
VLNT
breast reconstruction
postmastectomy lymphedema
vascularized lymph node transfer
lymphedema surgery
microsurgery
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases