Exploratory study of glycemic variability in the treatment course of pancreatic cancer patients using continuous glucose monitoring
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 主要终点
- Glycemic variability levels at registration
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 85age old under（—）
- 性别
- All
入选标准
- •(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
- •(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.
排除标准
- •(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.
结局指标
主要结局
Glycemic variability levels at registration
时间窗: At registration
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.
Glycemic variability levels at discharge after surgery
时间窗: Discharge after surgery
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.
Glycemic variability levels during postoperative adjuvant therapy
时间窗: During postoperative adjuvant therapy
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.
Glycemic variability levels post neoadjuvant therapy
时间窗: Post neoadjuvant therapy
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.
Glycemic variability levels in acute postoperative period
时间窗: Acute postoperative period
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.
Glycemic variability levels after completion of postoperative adjuvant therapy
时间窗: After completion of postoperative adjuvant therapy
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.
次要结局
- Association between glycemic variability and treatment adherence
- Relationship between glycemic variability and clinical symptoms