臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 26, 2024
Last modified on	July. 11, 2025
Trial ID	jRCTs052240137

Scientific Title	Analysis of blood glucose variability using continuous blood glucose monitoring in esophageal and gastric cancer patients planned for radical surgery
Public Title	Analysis of blood glucose variability using continuous blood glucose monitoring in esophageal and gastric cancer patients planned for radical surgery

Contact for Scientific Queries	Name	Motoori Masaaki
	Affiliation	Osaka General Medical Center
	Address	3-1-56, Mandai Higashi, Sumiyoshi-ku, Osaka city, Osaka, Japan
	Telephone	+81-666921201
	E-mail	motoorim@gh2.opho.jp
Contact for Public Queries	Name	Hirota Masashi
	Affiliation	Osaka General Medical Center
	Address	3-1-56, Mandai Higashi, Sumiyoshi-ku, Osaka city, Osaka, Japan
	Telephone	+81-666921201
	E-mail	hirotamas@gh2.opho.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 26, 2024
Actual date of first enrollment		Jan. 16, 2025
Target sample size		60
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	screening
Key inclusion & exclusion criteria	Inclusion Criteria	Cases of esophageal or gastric cancer planned for radical surgery. (1) histologically confirmed esophageal or gastric cancer (2) planned radical surgery (T: any, N: any, M: 0) (3) Dysphagia score: 0-2 (4) age: 20 years or older (5)ECOG performance status: 0-1 (6) no serious hepatic or renal dysfunction (7)Patient's written consent has been obtained
	Exclusion Criteria	Patients with (1) active multiple cancers (2) severe malabsorption (3) inflammatory bowel disease (4) diabetes requiring insulin therapy (5) allergy to Libresensor (6) extensive skin lesions, scars, infection, or edema, which make the application of the sensor difficult (7) taking pralidoxime methyl iodide (8) Cases deemed inappropriate by the physician (9) Patients with severe mental disorders
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Esophageal or gastric cancer cases planned for radical surgery
Intervention(s)		Continuous blood glucose monitoring preoperatively and postoperatively in esophageal and gastric cancer patients planned for radical surgery
Health Condition(s) Keyword		gastric cancer, esophageal cancer
Intervention(s) Keyword		continuous glucose monitoring
Health Condition(s) Code		D013274, D000077277
Intervention(s) Code		D000095583
Primary Outcome(s)		Preoperative and postoperative blood glucose trends (percentage of hyperglycemic and hypoglycemic time) in patients undergoing surgery for esophageal and gastric cancer
Secondary Outcome(s)		Association between questionnaire results (symptoms) and blood glucose levels, association between nutritional intake status (method of intake, caloric intake, type of nutritional supplements) and blood glucose levels, and association between surgical technique (reconstruction method) and blood glucose levels.

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Center Clinical Research Review Board
Address	3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka city, Osaka, Japan, Osaka
Telephone	+81-6-6692-1201
E-Mail	kenkyu-crb@gh2.opho.jp
Approval Status	Approval
Date of approval	Sept. 10, 2024

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	July. 11, 2025	(this page)	Changes
2	July. 09, 2025	Detail	Changes
1	Sept. 26, 2024	Detail

List of change history