Lymphaticovenous Anastomosis as Treatment for Lymphedema

O

Odense University Hospital

Status

Active, not recruiting

Conditions

Postoperative Complications
Breast Cancer Lymphedema
Postmastectomy Lymphedema Syndrome
Breast Cancer
Lymphedema of Upper Limb
Surgical; Lymphedema, Postmastectomy
Secondary Lymphedema
Surgery
Skin Diseases
Lymphatic Diseases
Iatrogenic Lymphedema
Pathologic Processes
Anastomose
Postmastectomy Lymphedema Syndrome Left Upper Limb
Lymphedema Arm
Lymphedema, Breast Cancer
Breast Neoplasm
Postmastectomy Lymphedema Syndrome Right Upper Limb
Breast Diseases
Neoplasms
Lymphedema
Postmastectomy Lymphedema

Treatments

Procedure: Lymphovenous anastomosis

Study type

Interventional

Funder types

Other

Identifiers

NCT05441943
S-20210169 (Other Identifier)
21/59848

Details and patient eligibility

About

The primary aim of this study is to investigate and test whether the use of combined indocyanine green (ICG) lymphography and ultra high frequency ultrasonography can correctly identify lymphatic vessels and venoles in close proximity to each other, for identification prior to lymphovenous anastomosis (LVA) surgery.

Full description

BACKGROUND Breast-cancer related lymphedema is a life-disabling side-effect of breast cancer treatment, affecting more than 1 in every 5 patients. With breast-cancer being the most common cancer diagnosis in women, affecting up to 2.3 million new cases globally, and with a generally high survival rate of 80% or higher in developed countries, the number of breast-cancer survivors with long-term sequela is significant. Compression garments have been considered the standard treatment and rehabilitation for lymphedema. Some of the disadvantages with these treatments include variability in patient compliance, clinical effect and lack of statistical significant results. Therefore, the rehabilitation and treatment options for lymphedema are in high demand, affecting patients physical and mental health. Lymphovenous anastomosis (LVA) surgery is an attempt to re-establish the lymphatic flow, utilizing the patient's own lymphatic- and venous vessels. Surgical treatment seems effective in selective patient groups, but systematic studies for this are lacking. It is based on this lack of knowledge of patient characteristics and preoperative planning that the project's hypothesis and idea was formed. Indocyanine green (ICG) lymphography is commonly used for identification of lymphatic vessels pre-operatively, and is considered superior to other modalities. However, until recently, the identification of adjacent venoles has remained a challenge. Ultra high frequency ultrasound may have solved the challenge of identifying the small venoles prior to surgery. The combined use of ICG lymphography and ultra high frequency ultrasound may be the key to optimise patient selection and pre-operative planning of lymphovenous anastomosis surgery. METHOD This study is designed as a pilot study with a planned inclusion of 10 patients with a 3 months follow-up period. The inclusion of patients, the surgical procedure and 3 months follow-up evaluation will take place at the Department of Plastic Surgery Odense University Hospital (OUH), Denmark. The ICG lymphography is performed by injecting ICG subcutaneously, and used for visualization of the superficial lymphatics for preoperative planning. During real-time visualization, lymphatic vessels are drawn up on the patients arm using a permanent marker. Ultra high frequency ultrasound (>30MHz) has the ability to visualize small, superficial anatomical layers. Using this ultra high frequency ultrasound (70MHz), following the mapped lymphatic vessels, venous vessels are found nearby and likewise mapped for anastomosis. The number of LVA anastomosis sites is set to a minimum of two sites per extremity. The number of mapped lymphatics vessels and venoles are compared to the number identified during surgery and recorded. Prior to and 3 months after surgery, patients are seen for objective measures of upper extremity volume, body composition, L-Dex score of the affected arm and health-related quality-of-life, in addition to ICG lymphography.

Enrollment

10 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female
  • Iatrogenic lymphedema following treatment for breast cancer in upper extremity
  • Possible to obtain informed consent
  • Age>18

Exclusion criteria

  • Duration of disease over 24 months
  • Smoker
  • Untreated or uncontrolled primary cancer
  • No applicable lymphatic vessels identified, using ICG lymphangiography
  • No applicable venous vessels identified using ultra high frequency ultrasound

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Lymphovenous anastomosis surgery
Experimental group
Description:
Lymphovenous anastomosis surgery with pre-operative planning using ICG lymphography and ultra high frequency ultrasound.
Treatment:
Procedure: Lymphovenous anastomosis

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Caroline Lilja, stud.med.

Data sourced from clinicaltrials.gov

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