Shinsuke Akita, Naoki Unno, Jiro Maegawa, Yoshihiro Kimata, Yusuke Ota, Yuichiro Yabuki, Akira Shinaoka, Masaki Sano, Fumio Ohnishi, Hisashi Sakuma, Takashi Nuri, Yoshihito Ozawa, Yuki Shiko, Yohei KawasakI, Michiko Hanawa, Yasuhisa Fujii, Eri Imanishi, Tadami Fujiwara, Hideki Hanaoka, Nobuyuki Mitsukawa
Journal of vascular surgery. Venous and lymphatic disorders 10(3) 728-737 2021年9月27日
OBJECTIVE: Indocyanine green fluorescent lymphography may be useful in patients undergoing lymphatic surgery for secondary lymphedema. This clinical trial aimed to confirm whether indocyanine green fluorescent lymphography is useful for evaluating lymphedema, identifying lymphatic vessels suitable for anastomosis, and confirming patency of a lymphaticovenular anastomosis in patients with secondary lymphedema. METHODS: This phase III, multicenter, single-arm, open-label clinical trial (HAMAMATSU-ICG study) investigated the accuracy of lymphedema diagnosis via indocyanine green fluorescent lymphography compared with lymphoscintigraphy, the identification rate of lymphatic vessels at the incision site, and the efficacy for confirming patency of a lymphaticovenular anastomosis. The external diameter of the identified lymphatic vessels and the distance from the skin surface to the lymphatic vessels based on preoperative indocyanine green fluorescent lymphography were measured intraoperatively under surgical microscopy. RESULTS: When the clinical decision for surgical indication at each research site was made, the standard diagnosis of lymphedema was considered to be correct. In 26 upper extremities, a central judgment committee blinded to the clinical presentation confirmed the imaging diagnosis as accurate in 100.0% of cases, whether assessments were made via lymphoscintigraphy or indocyanine green lymphography. In contrast, in 88 lower extremities, the accuracy rates of diagnosis based on those made by the central judgment committee were 70.5% and 88.2% for lymphoscintigraphy and indocyanine green lymphography, respectively. The external diameter of the identified lymphatic vessels was significantly greater in the lower extremities than in the upper extremities (0.54 ± 0.21 mm vs. 0.42 ± 0.14 mm, p < 0.0001), and the distance from the skin surface to the lymphatic vessels was significantly longer in the lower extremities than in the upper extremities (5.8 ± 3.5 mm vs. 4.4 ± 2.6 mm, p = 0.01). In 263 skin incisions determined using indocyanine green fluorescent lymphography findings, the identification rate of lymphatics vessels suitable for anastomosis was 97.7% (95% confidence interval: 95.1-99.2). In total, 267 lymphaticovenular anastomoses were performed. Indocyanine green fluorescent lymphography was judged as "useful" in confirming patency after anastomosis in 95.1% of cases. CONCLUSIONS: Indocyanine green fluorescent lymphography may be useful for improving the management of patients with secondary lymphedema from the outpatient setting to the operating room.