start-ver=1.4 cd-journal=joma no-vol=19 cd-vols= no-issue= article-no= start-page=100595 end-page= dt-received= dt-revised= dt-accepted= dt-pub-year=2020 dt-pub=202009 dt-online= en-article= kn-article= en-subject= kn-subject= en-title= kn-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 en-subtitle= kn-subtitle= en-abstract= kn-abstract=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. en-copyright= kn-copyright= en-aut-name=AkitaShinsuke en-aut-sei=Akita en-aut-mei=Shinsuke kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=1 ORCID= en-aut-name=UnnoNaoki en-aut-sei=Unno en-aut-mei=Naoki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=2 ORCID= en-aut-name=MaegawaJiro en-aut-sei=Maegawa en-aut-mei=Jiro kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=3 ORCID= en-aut-name=KimataYoshihiro en-aut-sei=Kimata en-aut-mei=Yoshihiro kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=4 ORCID= en-aut-name=FukamizuHidekazu en-aut-sei=Fukamizu en-aut-mei=Hidekazu kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=5 ORCID= en-aut-name=YabukiYuichiro en-aut-sei=Yabuki en-aut-mei=Yuichiro kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=6 ORCID= en-aut-name=ShinaokaAkira en-aut-sei=Shinaoka en-aut-mei=Akira kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=7 ORCID= en-aut-name=SanoMasaki en-aut-sei=Sano en-aut-mei=Masaki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=8 ORCID= en-aut-name=KawasakiYohei en-aut-sei=Kawasaki en-aut-mei=Yohei kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=9 ORCID= en-aut-name=FujiwaraTadami en-aut-sei=Fujiwara en-aut-mei=Tadami kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=10 ORCID= en-aut-name=HanaokaHideki en-aut-sei=Hanaoka en-aut-mei=Hideki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=11 ORCID= en-aut-name=MitsukawaNobuyuki en-aut-sei=Mitsukawa en-aut-mei=Nobuyuki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=12 ORCID= affil-num=1 en-affil=Department of Plastic, Reconstructive, and Aesthetic Surgery, Chiba University Graduate School of Medicine kn-affil= affil-num=2 en-affil=Department of Vascular Surgery, Hamamatsu Medical Center kn-affil= affil-num=3 en-affil=Department of Plastic and Reconstructive Surgery, Yokohama City University, Graduate School of Medicin kn-affil= affil-num=4 en-affil=Department of Plastic and Reconstructive Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science kn-affil= affil-num=5 en-affil=Department of Plastic and Reconstructive Surgery, Hamamatsu University School of Medicine kn-affil= affil-num=6 en-affil=Department of Plastic and Reconstructive Surgery, Yokohama City University, Graduate School of Medicine kn-affil= affil-num=7 en-affil=Department of Plastic and Reconstructive Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science kn-affil= affil-num=8 en-affil=Second Department of Surgery, Hamamatsu University School of Medicine kn-affil= affil-num=9 en-affil=Clinical Research Center, Chiba University Hospital kn-affil= affil-num=10 en-affil=Clinical Research Center, Chiba University Hospital kn-affil= affil-num=11 en-affil=Clinical Research Center, Chiba University Hospital kn-affil= affil-num=12 en-affil=Department of Plastic, Reconstructive, and Aesthetic Surgery, Chiba University Graduate School of Medicine kn-affil= en-keyword=Indocyanine green fluorescent lymphography kn-keyword=Indocyanine green fluorescent lymphography en-keyword=Secondary lymphoedema kn-keyword=Secondary lymphoedema en-keyword=Lymphaticovenular anastomosis kn-keyword=Lymphaticovenular anastomosis END