Prospective Cohort Study on Endo-Exdo Secretory Function Alterations and All-round Outcomes After Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of Participants Who developed glucose metabolic disorders(pre-diabetes and diabetes mellitus)
研究概览
简要总结
The goal of this observational study is to learn about post-surgery of pancreatic cancer diabetes mellitus.The main questions it aims to answer are:
- Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same?
- Are alterations in endocrine and exdocrine secretory function in patients with pancreatic surgery associated with all-round outcomes? All patients with pancreatic surgery have been given the standardized treatment for the condition.
The reasearchers will summarize the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) during different surgical procedures to explore the association between alternations in endocrine and exdocrine secrectory function and all-round outcomes.
详细描述
Investigators will prospectively collect data from patients with pancreatic cancer after surgery in participant centers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female Chinese subjects;
- •Age ≥ 18 years;
- •patients with pancreatic cancer who are proposed to undergo pancreatectomy by pancreaticobiliary surgery at our hospital;
- •those who voluntarily completed the Pancreatobiliary Surgery Cohort Study and signed the informed consent;
- •those who have completed and banked serum and pathological specimens at our hospital.
排除标准
- •those with a previous history of comorbid diabetes mellitus or pre-diabetes mellitus, or preoperative HbA1C ≥ 6.0% or fasting blood glucose ≥ 6.1 mmol/l;
- •those with positive islet-associated antibodies
- •those with the presence of medications, endocrine disease exposures that can lead to a risk of secondary diabetes;
- •pregnant or nursing women;
- •Cognitive impairment or other reasons for failing to sign the informed consent form.
结局指标
主要结局
Number of Participants Who developed glucose metabolic disorders(pre-diabetes and diabetes mellitus)
时间窗: From enrollment to five years after the end of the surgery
The diagnosis of glucose disorders should be made applying criteria of the American Diabetes Association.
次要结局
- Overall Survival(From enrollment to five years after the end of the surgery)
- Disease-Free Survival(From enrollment to five years after the end of the surgery)
研究者
LiTuo
Deputy Director
Shanghai Changzheng Hospital