Microvascular Breast Reconstruction With Lymph Node Transfer

November 26, 2020 updated by: Ahmed ElSayed Sharaf Ahmed, Assiut University

Evaluation of Outcomes of Microvascular Breast Reconstruction With Lymph Node Transfer for Postmastectomy Lymphedema Patients

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-12 months
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
6-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6-12 months
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.
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 18, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VLNT for lymphedema

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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