A protocol for a prospective single-arm feasibility study of preoperative home-based hydrogen gas inhalation in liver surgery
Naruhiko Honmyo, Tsuyoshi Kobayashi, Shintaro Kuroda, Masateru Yamamoto, Yuki Imaoka, Naoki Tanimine, Seiichi Shimizu, Tomoyuki Abe, Hiroyuki Tahara, Masahiro Ohira, Kentaro Ide, Eiji Kobayashi, Hideki OhdanIntroduction:
Hydrogen therapy has been reported to exert antioxidative and anti-inflammatory effects and has attracted increasing clinical interest across various medical fields. In cancer treatment, a waiting period often exists between the treatment decision and surgery; however, structured and evidence-based preoperative interventions during this interval remain limited. Home-based hydrogen gas inhalation, which enables long-duration, repeated administration, may represent a feasible and practical strategy for preoperative optimization. This study aims to evaluate the safety and feasibility of a standardized home-based hydrogen gas inhalation protocol in patients scheduled for liver resection.
Methods:
This is a prospective, single-center, single-arm, open-label exploratory clinical trial with a planned enrollment of eight participants. Eligible patients scheduled for liver resection will undergo home-based hydrogen gas inhalation during sleep and, additionally, for approximately 1 hour each morning and evening for 14 consecutive days in the preoperative waiting period. The primary endpoint is feasibility, defined as protocol adherence based on predefined inhalation duration criteria. Safety will be assessed by the incidence of adverse events. Secondary and exploratory assessments include changes in inflammation-related, immune-related, and nutrition-related indices, oxidative stress markers, body composition parameters, questionnaire-based quality of life, and tumor markers. This study is registered in the Japan Registry of Clinical Trials (jRCT: jRCTs062250073).
Conclusion:
This study protocol is designed to evaluate the feasibility and safety of preoperative home-based hydrogen gas inhalation and to generate preliminary data to inform the design of subsequent clinical trials investigating its potential role in perioperative care for liver surgery.