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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 researchmap
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
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.
キーワード
Indocyanine green fluorescent lymphography
Secondary lymphoedema
Lymphaticovenular anastomosis
発行日
2020-09
出版物タイトル
Contemporary Clinical Trials Communications
19巻
出版者
Elsevier
開始ページ
100595
ISSN
2451-8654
資料タイプ
学術雑誌論文
言語
English
OAI-PMH Set
岡山大学
著作権者
© 2020 The Authors.
論文のバージョン
publisher
PubMed ID
DOI
Web of Science KeyUT
関連URL
isVersionOf https://doi.org/10.1016/j.conctc.2020.100595
ライセンス
http://creativecommons.org/licenses/by/4.0/
助成機関名
Japan Agency for Medical Research and Development
助成番号
JMA-CCT-A-2704