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

JRCT ID: jRCTs052240137

Registered date:26/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal or gastric cancer cases planned for radical surgery
• Date of first enrollment: 26/09/2024
• Target sample size: 60
• Study type: Observational
• Intervention(s): Continuous blood glucose monitoring preoperatively and postoperatively in esophageal and gastric cancer patients planned for radical surgery

Outcome(s)

• Primary Outcome: Preoperative and postoperative blood glucose trends (percentage of hyperglycemic and hypoglycemic time) in patients undergoing surgery for esophageal and gastric cancer
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Motoori Masaaki
• Secondary Sponsor: Masashi Hirota