Esophageal cancer Esophageal cancer, non-diabetic, enteral feeding, carbohydrate restriction
Conditions
Interventions
Enteral nutrition with restricted carbohydrate, monitoring with continuous glucose monitoring device.
Enteral nutrition with restricted carbohydrate, continuous glucose monitoring
Sponsors
Watanabe Masayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically diagnosed esophageal cancer. Any histological type is acceptable. (2) Patient has no history of diabetes (HbA1c less than 6.5 at the time of initial examination). (3) The planned surgery is subtotal esophagectomy with gastric tube reconstruction. (4) Age at the time of enrollment is 20 years or older. (5) Consent to participate in the study has been obtained after a thorough explanation of the study. (6) Patients have preserved organ function and are tolerant to general anesthesia.
Exclusion criteria
Exclusion criteria: 1) Patients with distant metastasis. 2) Patients who underwent palliative resection. 3) Patients who underwent two-stage reconstruction. 4) Patients who underwent total pharyngolaryngo-esophagectomy. 5) Patients who required combined resection of the thoracic duct. 6) Patients in which preoperative chemoradiotherapy was performed. 7) Patients in which prophylactic administration of steroids was not performed due to unavoidable reasons. 8) Patients in which an implanted medical device such as a pacemaker is used.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Time in range (TIR) up to the second postoperative day as measured by CGM | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. rate of infectious complications during hospitalization 2. rate of infectious complications within 30 days after surgery 3. rate of all complications during hospitalization 4. rate of adverse events associated with enteral nutrition 5. Mean TAR during the entire measurement period (postoperative days 1-8) as measured by CGM 6. TAR for each day up to the 8th postoperative day measured by CGM 7. Mean AUC during the entire measurement period (postoperative days 1-8) measured by CGM 8. AUC for each day up to postoperative day 8 measured by CGM 9. Mean value of TIR during the entire measurement period (postoperative days 1-8) measured by CGM 10. TIR for each day up to postoperative day 8 as measured by CGM 11. Percentage change in nutritional indices during the hospitalization period compared to the time of admission (albumin level, prealbumin level, and total protein level of serum) 12. Number of cases of glycemic control intervention for hyperglycemia criteria (>=201 mg/dL) 13. Number of cases of enteral feedings changed on postoperative day 3 or later 14. Number of cases requiring enteral nutritional supplements reduction by 50% or more on postoperative day 3 or later compared to the previous day 15. Mean TAR during the entire measurement period (postoperative days 1-8) as measured by CGM and percentage of infectious complications during hospitalization 16. Mean TAR during the entire measurement period (postoperative days 1-8) as measured by CGM and the percentage of infectious complications within 30 days postoperatively 17. Mean AUC during the entire measurement period (postoperative days 1-8) measured by CGM and percentage of infectious complications during hospitalization 18. Mean AUC during the entire measurement period (postoperative days 1-8) measured by CGM and percentage of infectious complications within 30 days after surgery 19. Mean TIR during the entire measurement period (postoperative days 1-8) measured by CGM and percentage of infectious complicatio | — |
Contacts
Public ContactYu Imamura
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Outcome results
None listed