Continuous glucose monitoring for pancreatic cancer patients

JRCT ID: jRCTs042230142

Registered date:18/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cases scheduled for pancreatoduodenectomy for resectable pancreatic cancer.
• Date of first enrollment: 22/03/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Using a continuous glucose monitoring device to monitor glycemic variability throughout the treatment process in cases of pancreatic cancer.

Outcome(s)

Primary Outcome

The glycemic variability levels measured during each period of the treatment course for pancreatic cancer patients:
Glucose concentrations are measured every 15 minutes for up to 14 days in a single session.
Measurements taken for three days or more per session are considered valid.
(1) At registration
(2) Post neoadjuvant therapy
(3) Acute postoperative period
(4) Discharge after surgery
(5) During postoperative adjuvant therapy
(6) After completion of postoperative adjuvant therapy

Secondary Outcome

(1) Association between glycemic variability and treatment adherence
Presence of preoperative complications, impact on the initiation of NAC (Neoadjuvant Chemotherapy)
Adherence to NAC
Impact on the start of surgery
Postoperative complications, impact on the initiation of adjuvant therapy after surgery
Adherence to postoperative adjuvant therapy
(2) Relationship between glycemic variability and clinical symptoms (weight changes, nutritional status[Alb, T-chol, Lymphocyte, PNI, NLR, PLR, CONUT)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

(1) Cases diagnosed with resectable pancreatic cancer.
(2) Cases scheduled for pancreatoduodenectomy.
(3) The age at the time of consent acquisition is between 18 and 85 years.
(4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is 0 or 1.
(5) Meets all the following conditions based on the latest preoperative test values within 30 days before registration:
- White blood cell count: >=2,500/uL and <=10,000/uL
- Platelet count >=10/*10^4uL
- AST (Aspartate Aminotransferase): <=100U/L
- ALT (Alanine Aminotransferase): <=100U/L
- Total bilirubin: <=2.0 mg/dL (or <=4.0 mg/dL for cases with biliary drainage due to jaundice)
- Serum creatinine: <=1.5 mg/dL
(6) Written consent for participation in the trial has been obtained from the patient.

Exclude criteria

(1) Cases undergoing pancreatic resection other than pancreatoduodenectomy (such as total pancreatectomy,distal pancreatectomy, central pancreatectomy, or local pancreatectomy).
(2) Undergoing continuous glucose monitoring for diabetes.
(3) Cases deemed unsuitable as subjects for this trial by the attending physician.

Related Information

• Primary Sponsor: Sugiura Teiichi