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临床试验/NCT06585072
NCT06585072招募中不适用

Prospective Cohort Study on Endo-Exdo Secretory Function Alterations and All-round Outcomes After Pancreatic Cancer

Shanghai Changzheng Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年1月3日最近更新:
适应症

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:

  1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same?
  2. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

LiTuo

Deputy Director

Shanghai Changzheng Hospital

研究点 (1)

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