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HAMAMATSU-ICG study: Protocol for a phase III, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema
INTRODUCTION: Secondary lymphoedema of the extremities is an important quality-of-life issue for patients who were treated for their malignancies. Indocyanine green (ICG) fluorescent lymphography may be helpful for assessing lymphoedema and for planning lymphaticovenular anastomosis (LVA). The objec...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322679/ https://www.ncbi.nlm.nih.gov/pubmed/32617434 http://dx.doi.org/10.1016/j.conctc.2020.100595 |
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author | Akita, Shinsuke Unno, Naoki Maegawa, Jiro Kimata, Yoshihiro Fukamizu, Hidekazu Yabuki, Yuichiro Shinaoka, Akira Sano, Masaki Kawasaki, Yohei Fujiwara, Tadami Hanaoka, Hideki Mitsukawa, Nobuyuki |
author_facet | Akita, Shinsuke Unno, Naoki Maegawa, Jiro Kimata, Yoshihiro Fukamizu, Hidekazu Yabuki, Yuichiro Shinaoka, Akira Sano, Masaki Kawasaki, Yohei Fujiwara, Tadami Hanaoka, Hideki Mitsukawa, Nobuyuki |
author_sort | Akita, Shinsuke |
collection | PubMed |
description | INTRODUCTION: Secondary lymphoedema of the extremities is an important quality-of-life issue for patients who were treated for their malignancies. Indocyanine green (ICG) fluorescent lymphography may be helpful for assessing lymphoedema and for planning lymphaticovenular anastomosis (LVA). The objective of the present clinical trial is to confirm whether or not ICG fluorescent lymphography using the near-infrared monitoring camera is useful for assessing the indication for LVA, for the identification of the lymphatic vessels before the conduct of LVA, and for the confirmation of the patency of the anastomosis site during surgery. METHODS AND ANALYSIS: This trial is a phase III, multicentre, single-arm, open-label clinical trial to assess the efficacy and safety of ICG fluorescent lymphography when assessing and treating lymphoedema of patients with secondary lymphoedema who are under consideration for LVA. The primary endpoint is the identification rate of the lymphatic vessels at the incision site based on ICG fluorescent lymphograms obtained before surgery. The secondary endpoints are 1) the sensitivity and specificity of dermal back flow determined by ICG fluorescent lymphography as compared with (99m)Tc lymphoscintigraphy—one of the standard diagnostic methods and 2) the usefulness of ICG fluorescent lymphography when confirming the patency of the anastomosis site after LVA. ETHICS AND DISSEMINATION: The protocol for the study was approved by the Institutional Review Board of each institution. The trial was filed for and registered at the Pharmaceuticals and Medical Devices Agency in Japan. The trial is currently on-going and is scheduled to end in June 2020. TRIAL REGISTRATION NUMBER: jRCT2031190064; Pre-results. |
format | Online Article Text |
id | pubmed-7322679 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-73226792020-07-01 HAMAMATSU-ICG study: Protocol for a phase III, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema Akita, Shinsuke Unno, Naoki Maegawa, Jiro Kimata, Yoshihiro Fukamizu, Hidekazu Yabuki, Yuichiro Shinaoka, Akira Sano, Masaki Kawasaki, Yohei Fujiwara, Tadami Hanaoka, Hideki Mitsukawa, Nobuyuki Contemp Clin Trials Commun Article INTRODUCTION: Secondary lymphoedema of the extremities is an important quality-of-life issue for patients who were treated for their malignancies. Indocyanine green (ICG) fluorescent lymphography may be helpful for assessing lymphoedema and for planning lymphaticovenular anastomosis (LVA). The objective of the present clinical trial is to confirm whether or not ICG fluorescent lymphography using the near-infrared monitoring camera is useful for assessing the indication for LVA, for the identification of the lymphatic vessels before the conduct of LVA, and for the confirmation of the patency of the anastomosis site during surgery. METHODS AND ANALYSIS: This trial is a phase III, multicentre, single-arm, open-label clinical trial to assess the efficacy and safety of ICG fluorescent lymphography when assessing and treating lymphoedema of patients with secondary lymphoedema who are under consideration for LVA. The primary endpoint is the identification rate of the lymphatic vessels at the incision site based on ICG fluorescent lymphograms obtained before surgery. The secondary endpoints are 1) the sensitivity and specificity of dermal back flow determined by ICG fluorescent lymphography as compared with (99m)Tc lymphoscintigraphy—one of the standard diagnostic methods and 2) the usefulness of ICG fluorescent lymphography when confirming the patency of the anastomosis site after LVA. ETHICS AND DISSEMINATION: The protocol for the study was approved by the Institutional Review Board of each institution. The trial was filed for and registered at the Pharmaceuticals and Medical Devices Agency in Japan. The trial is currently on-going and is scheduled to end in June 2020. TRIAL REGISTRATION NUMBER: jRCT2031190064; Pre-results. Elsevier 2020-06-16 /pmc/articles/PMC7322679/ /pubmed/32617434 http://dx.doi.org/10.1016/j.conctc.2020.100595 Text en © 2020 The Authors http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Akita, Shinsuke Unno, Naoki Maegawa, Jiro Kimata, Yoshihiro Fukamizu, Hidekazu Yabuki, Yuichiro Shinaoka, Akira Sano, Masaki Kawasaki, Yohei Fujiwara, Tadami Hanaoka, Hideki Mitsukawa, Nobuyuki HAMAMATSU-ICG study: Protocol for a phase III, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema |
title | HAMAMATSU-ICG study: Protocol for a phase III, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema |
title_full | HAMAMATSU-ICG study: Protocol for a phase III, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema |
title_fullStr | HAMAMATSU-ICG study: Protocol for a phase III, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema |
title_full_unstemmed | HAMAMATSU-ICG study: Protocol for a phase III, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema |
title_short | HAMAMATSU-ICG study: Protocol for a phase III, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema |
title_sort | hamamatsu-icg study: protocol for a phase iii, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322679/ https://www.ncbi.nlm.nih.gov/pubmed/32617434 http://dx.doi.org/10.1016/j.conctc.2020.100595 |
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