ID | 61177 |
フルテキストURL | |
著者 |
Akita, Shinsuke
Department of Plastic, Reconstructive, and Aesthetic Surgery, Chiba University Graduate School of Medicine
Unno, Naoki
Department of Vascular Surgery, Hamamatsu Medical Center
Maegawa, Jiro
Department of Plastic and Reconstructive Surgery, Yokohama City University, Graduate School of Medicin
Kimata, Yoshihiro
Department of Plastic and Reconstructive Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Kaken ID
publons
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Fukamizu, Hidekazu
Department of Plastic and Reconstructive Surgery, Hamamatsu University School of Medicine
Yabuki, Yuichiro
Department of Plastic and Reconstructive Surgery, Yokohama City University, Graduate School of Medicine
Shinaoka, Akira
Department of Plastic and Reconstructive Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Kaken ID
researchmap
Sano, Masaki
Second Department of Surgery, Hamamatsu University School of Medicine
Kawasaki, Yohei
Clinical Research Center, Chiba University Hospital
Fujiwara, Tadami
Clinical Research Center, Chiba University Hospital
Hanaoka, Hideki
Clinical Research Center, Chiba University Hospital
Mitsukawa, Nobuyuki
Department of Plastic, Reconstructive, and Aesthetic Surgery, Chiba University Graduate School of Medicine
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抄録 | 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 99mTc 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.
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キーワード | Indocyanine green fluorescent lymphography
Secondary lymphoedema
Lymphaticovenular anastomosis
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発行日 | 2020-09
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出版物タイトル |
Contemporary Clinical Trials Communications
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巻 | 19巻
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出版者 | Elsevier
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開始ページ | 100595
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ISSN | 2451-8654
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資料タイプ |
学術雑誌論文
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言語 |
英語
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OAI-PMH Set |
岡山大学
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著作権者 | © 2020 The Authors.
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論文のバージョン | publisher
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PubMed ID | |
DOI | |
Web of Science KeyUT | |
関連URL | isVersionOf https://doi.org/10.1016/j.conctc.2020.100595
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ライセンス | http://creativecommons.org/licenses/by/4.0/
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助成機関名 |
Japan Agency for Medical Research and Development
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助成番号 | JMA-CCT-A-2704
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