Enteral Nutrition formula with Low Carbohydrate on Postoperative Hyperglycemia in Non-Diabetic Patients

JRCT ID: jRCTs031240081

Registered date:13/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 01/06/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Enteral nutrition with restricted carbohydrate, monitoring with continuous glucose monitoring device.

Outcome(s)

• Primary Outcome: Mean Time in range (TIR) up to the second postoperative day as measured by CGM

Secondary Outcome

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 (>=300 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

Key inclusion & exclusion criteria

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

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Watanabe Masayuki