臨床研究等提出・公開システム

Date of registration	May. 22, 2024
Last modified on	June. 22, 2026
Trial ID	jRCT1031240102

Scientific Title	A safety epidemiological study assessing the effect of Daikenchuto (TJ-100) on the risk of liver injury in cancer patients who underwent colectomy or gastrectomy
Public Title	A safety epidemiological study assessing the effect of Daikenchuto (TJ-100) on the risk of liver injury in cancer patients who underwent colectomy or gastrectomy

Result actual enrolment	51133
Baseline Characteristics	stomach cancer or colon cancer
Brief summary	No assossiation between TJ-100 administration post-colectomy/gastrectomy and the risk of postoperative hepatobiliary injury was identified.
Date of the first journal publication of results	Nov. 28, 2025
URL hyperlink(s) related to results and publications	https://doi.org/10.1248/bpb.b25-00439,https://doi.org/10.1186/s12906-025-05186-1

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1031240102

Contact for Scientific Queries	Name	asakawa takeshi
	Affiliation	TSUMURA & CO.
	Address	3586 Yoshiwara, Ami-machi, Inashiki-gun, Ibaraki
	Telephone	+81-29-889-3862
	E-mail	tsu_jp_rd_ds01@mail.tsumura.co.jp
Contact for Public Queries	Name	wada yuu
	Affiliation	TSUMURA & CO.
	Address	3586 Yoshiwara, Ami-machi, Inashiki-gun, Ibaraki
	Telephone	+81-29-889-3862
	E-mail	tsu_jp_rd_ds01@mail.tsumura.co.jp

Recruitment status	Complete

Study Design
Anticipated date of first enrollment		May. 22, 2024
Study Type		Observational



	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Colon cancer patients who underwent colon surgery and gastric cancer patients who underwent gastrectomy between April 2008 and May 2019
	Exclusion Criteria	Patients who meet the following criteria will be excluded. Cancer patients who underwent complex surgery Patients who underwent hepatectomy Patients diagnosed with liver comorbidities before surgery Patients who were prescribed choleretic agents or hepatoprotective drugs before surgery Patients prescribed antibiotics before surgery Patients prescribed anti-tumor drugs before surgery Patients who received blood transfusion on the day before surgery
	Age Minimum	No limit
	Age Maximum	No limit

Health Condition(s) or Problem(s) Studied		stomach cancer
Primary Outcome(s)		Whether there is a record of being prescribed choleretic agents or liver-protecting drugs
Secondary Outcome(s)		Whether there is a record of being prescribed a choleretic agent or a liver-protecting drug and a steroid preparation.

Primary Sponsor	TSUMURA & CO.

Name of Certified Review Board	Shiba Palace Clinic Ethics Review Committee
Address	1-9-10 Hamamatsucho, Minato-ku, Tokyo, Tokyo
Approval Status	Approval

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
3	June. 22, 2026	(this page)	Changes
2	Nov. 11, 2025	Detail	Changes
1	May. 22, 2024	Detail

List of change history