Table 2 Trial data
Primary registry and trial identifying number | Japan Registry of Clinical Trial (jRCT): no. 03220332 |
Date of registration in primary registry | Approved on 21 January 2021 |
Secondary identifying numbers | Niigata University Central Review Board of Clinical Research: SP20004 |
Source of monetary or material support | Helix Japan K.K. |
Primary sponsor | Helix Japan K.K. |
Secondary sponsor(s) | None |
Contact for public queries | Masaki Kaibori MD., PhD. Professor Department of Surgery, Kansai Medical University Email: kaibori@hirakata.kmu.ac.jp Postal address: 2-5-1 Shinmachi, Hirakata city, Osaka, Japan. 573-1010 TEL: +81-72-804-0101 |
Contact for scientific queries | Same as above |
Public title | Effect of inhalation of hydrogen gas on postoperative recovery |
Scientific title | Effect of inhalation of hydrogen gas on post-hepatectomy recovery Double-blind randomized controlled trial |
Countries of recruitment | Japan |
Health condition or problem studied | Hepatobiliary diseases |
Intervention(s) | Inhalation of hydrogen gas |
Key inclusion and exclusion criteria | Inclusion criteria: 1. 20 years old and older (regardless of gender) 2. Patient has undergone hepatic resection for hepatobiliary cancer (regardless of the operative procedure, range of hepatectomy, and primary disease) 3. Patient who accepts entry to this study with free will after sufficient explanation Exclusion criteria: 1. Severe liver dysfunction or severe renal dysfunction 2. Uncontrollable diabetes mellitus 3. Pregnancy or possibility of being pregnant 4. Lactating patient 5. Patient who received another test agent or investigational agent within three months prior to agreement for this study 6. Patient who required combined other organ resection (stomach, colon, lung, and so on) 7. Patient who required biliary tract reconstruction 8. Patient who required emergency surgery (HCC rupture) 9. Patient who is considered as inadequate by the principal investigator of this study |
Study type | Interventional, randomized controlled trial/double blind/placebo or control/parallel assignment/treatment purpose |
Date of first enrollment | 9 March 2021 |
Sample size | 68 |
Recruitment status | Recruiting |
Primary outcome | QoR40 of postoperative day 3 |
Key secondary outcomes | 1. QoR40 except postoperative day 3 2. Postoperative complications (Clavien-Dindo score) 3. Wound pain (Numerical Rating Scale) 4. Dietary intake 5. The number of steps taken 6. Inflammatory response (WBC, CRP, neutrophils, lymphocyte) 7. Liver functions (total bilirubin, AST, ALT, ALP, albumin, thrombocyte, PT, ICG) 8. Reactive oxygen value (urinary 8-OHdG) 9. Adverse event 10. Time of inhalation of hydrogen gas |
Ethics review | Approved Approved number: SP20004 Date of approval: 19 January 2021 Ethics committee: Niigata University Central Review Board of Clinical Research Address: 1-754, Asahimachi-dori, Chuo-ku, Niigata city, Japan, Niigata |
Completion date | 31 December 2023 |
Summary results | No results for now |
IPD sharing statement | Plan to share IPD: no |