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

Shinsuke Akita, Naoki Unno, Jiro Maegawa, Yoshihiro Kimata, Hidekazu Fukamizu, Yuichiro Yabuki, Akira Shinaoka, Masaki Sano, Yohei Kawasaki, Tadami Fujiwara, Hideki Hanaoka, Nobuyuki Mitsukawa

Research output: Contribution to journalArticle

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. Trial registration number: jRCT2031190064; Pre-results.

Original languageEnglish
Article number100595
JournalContemporary Clinical Trials Communications
Volume19
DOIs
Publication statusPublished - Sep 2020

Keywords

  • Indocyanine green fluorescent lymphography
  • Lymphaticovenular anastomosis
  • Secondary lymphoedema

ASJC Scopus subject areas

  • Pharmacology

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