Histologic Analysis of the Lymphatic Vessels Used for Supermicrosurgical Lymphatico-venous Anastomoses in Lymphedema (s-LVA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03465930|
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment|
|Lymphedema||Procedure: Supermicrosurgical lymphatico-venous anastomoses|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Histologic Analysis of the Lymphatic Collecting Vessels Used for Minimally Invasive Supermicrosurgical Lymphatico-venous Anastomoses in the Treatment of Lymphedema|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2023|
Patients with lymphedema
Patients affected by primary or secondary lymphedema. The intervention will consist in supermicrosurgical lymphatico-venous anastomoses (sLVA) to allow drainage of the lymph in the venous stream distal to the obstruction. sLVA is a minimally invasive procedure performed under local anesthesia. It requires an accurate visualization of the lymphatic vessels that are still functional.
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.
- Expression of the lymphatic endothelial marker D2-40 in relation with the duration of lymphedema. [ Time Frame: Collection of samples from different sites of at least 10 patients will require at least 6 months ]On sections stained with D2-40, under light microscopy with the aid of the morphometric program NIS elements tracing the portions of the endothelium stained positively for this marker and comparing the sum of all positive segments of each vessel with the length of its inner profile. The duration of lymphedema in number of years can be obtained using previous medical records (e.g. lymphography or lymphoscintigraphy) when the patient comes to observation after the diagnosis has already been made or, when no previous medical record is available, through the anamnesis. The duration of lymphedema from clinical onset to the time of surgery is expressed in number of years.
- Area of the vessel wall versus area of the lumen [ Time Frame: Collection of samples from different sites of at least 10 patients will require at least 6 months ]Subtracting the inner from the outer profile with the aid of the morphometric program NIS elements.
- The relative proportion of smooth muscle cells and collagen fibers in the lymphatic vessel wall. [ Time Frame: Collection of samples from different sites of at least 10 patients will require at least 6 months ]Staining with Trichrome stain and measuring the threshold of the stained area (threshold of red for smooth muscle cells, threshold of blue for collagen fibers).
- Differences in the histology of lymphatics between primary and secondary lymphedema. [ Time Frame: Since primary lymphedema is rare, collection of an adequate number of cases of primary lymphedema (at least 10) to evaluate whether there are histologic differences with secondary lymphedema will require at least three years. ]Histologic measurements are the same as for the primary outcome. To determine if the lymphedema is primary or secondary an accurate anamnesis is usually enough: patients report history of trauma or cancer treatment in case of secondary lymphedema, no such events in primary lymphedema.
- Relation between the anatomic site of the anastomosis and histologic parameters. [ Time Frame: Collection of samples from different sites of at least 10 patients will require at least 6 months. ]Measurement of histologic parameters as in the primary outcome, comparison between samples taken from different sites of the same patient (hand or wrist versus elbow, or more rarely arm, for the upper limb, foot or ankle versus knee or more rarely thigh, for the lower limb).
- Correlation between histologic modifications and morphologic appearance at lymphography and / or at MRL (Magnetic Resonance Lymphography). [ Time Frame: Collection of samples from different sites of at least 10 patients will require at least 6 months ]Lymphography with a fluorescent dye (indocyanine green), routinely performed prior to surgery to choose the lymphatic vessels suitable for anastomoses. In later stage lymphedemas, MRL, with gadolinium as a contrast medium, is sometimes necessary to allow visualization of lymphatic vessels thanks to the slow wash out of gadolinium. Histologic evaluation as in the primary outcome.
Biospecimen Retention: Samples Without DNA
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): NCT03465930
|Contact: Paolo Gennaro, MD, PhDemail@example.com|
|Contact: Elisabetta Weber, MDfirstname.lastname@example.org|
|Dept. of Maxillofacial Surgery, Azienda Ospedaliera Universitaria Senese||Recruiting|
|Siena, Italy, 53100|
|Contact: Paolo Gennaro, MD, PhD +390577585447 email@example.com|
|Contact: Elisabetta Weber, MD +390577234083 firstname.lastname@example.org|
|Sub-Investigator: Virginia Barone, PhD|
|Sub-Investigator: Annalisa Borghini, PhD|
|Sub-Investigator: Guido Gabriele, MD|
|Sub-Investigator: Erica Tedone Clemente, MD|
|Study Director:||Paolo Gennaro, MD, PhD||Department of Biotechnology, University of Siena; Department of Maxillofacial Surgery, Azienda Ospedaliera Universitaria Senese|
|Principal Investigator:||Elisabetta Weber, MD||University of Siena, Dept. of Molecular and Developmental Medicine.|