Histologic Analysis of the Lymphatic Vessels Used for Supermicrosurgical Lymphatico-venous Anastomoses in Lymphedema

Summary

Lymphedema, primary or secondary, is a chronic disease that causes functional impairment and has an important impact on patient's quality of life. Lymphedema can be primary or secondary. Secondary lymphedema, which is more common, especially in industrialized countries, is often due to surgery and radiotherapy to treat cancer. There is no definite cure for lymphedema; conservative treatments such as elastic compression garments, bandages and manual lymphatic drainage help reducing the edema but do not resolve it. Many types of surgery have been used in the past, the most recent are lymphatic-venous anastomoses, a minimally invasive procedure that may be performed under local anesthesia. Briefly, after visualizing the lymphatic vessels with a fluorescent dye, one or more anastomosis are created between collecting lymphatic vessels and superficial veins in order to drain the lymph into the blood stream bypassing the obstacle. During this procedure, it is possible to take samples of the collecting lymphatic vessels that are to be anastomosed with veins and use them for histological and immunohistochemical studies, without causing any additional discomfort to the patient. These samples can be formalin fixed and paraffin embedded. The obtained sections will be stained with a lymphatic endothelium marker and a smooth muscle specific stain. A morphometric study will be conducted and, based on the results a statistical evaluation will be made. The analysis will be conducted on samples obtained from patients, affected by secondary or primary lymphedema willing to provide their free and informed consent. The aim of this study is to evaluate the histopathological characteristics of the collecting lymphatic vessels that have been anastomosed with adjacent veins during surgery, and relate the results with the obtained clinical response. The acquired knowledge will contribute to optimize the clinical approach to prevent and treat lymphedema, by helping to select the patients that will benefit more from the surgery, and to select vessels and anatomical sites that have better chances to provide efficient anastomoses.

Conditions

• Lymphedema

Interventions

PROCEDURE

Supermicrosurgical lymphatico-venous anastomoses

Supermicrosurgical lymphatico-venous anastomoses (sLVA) require an accurate visualization of the lymphatic vessels that are still functional. Lymphatic vessels are visualized with lymphography using a fluorescent dye, indocyanine green. Adjacent superficial veins mapping is obtained with Accuvein device.

Sponsors & Collaborators

• Elisabetta Weber, MD

  collaborator UNKNOWN

• Paolo Gennaro

  lead OTHER

Principal Investigators

• Paolo Gennaro, MD, PhD · Department of Biotechnology, University of Siena; Department of Maxillofacial Surgery, Azienda Ospedaliera Universitaria Senese

• Elisabetta Weber, MD · University of Siena, Dept. of Molecular and Developmental Medicine.

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-01

Primary Completion

2018-12-31

Completion

2023-12-31

Countries

• Italy

Study Locations