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临床试验/NCT01988350
NCT01988350已完成不适用

Pancreatic Insufficiency Secondary to Tobacco Exposure

Emory University1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
202
试验地点
1
主要终点
pancreatic insufficency

研究概览

简要总结

Pancreatic insufficiency is a condition in which there is a decrease in the production and release of enzymes made in the pancreas, which causes nutrient malabsorption. There are many chronic diseases that can lead to pancreatic insufficiency. In the early stages of this disease, a patient may not experience any symptoms, and the prevalence of pancreatic insufficiency may be underestimated. Smoking has long been recognized as a cause of disease in many organs in the body. Cigarette smoke causes inflammation and damages tissue, including the pancreas. Studies have shown that smoking is an independent risk factor for pancreatic cancer and chronic pancreatitis. It has also been shown that the more a person smokes, the worse his disease will be. Additionally, there are studies that show that smokers have nutritional deficiencies. There are observational and retrospective studies that suggest that pancreatic insufficiency may also be caused by smoking. However, this has not been established, and the relationship has not been examined in a controlled manner. This study examines the relationship between smoking and pancreatic insufficiency in patients who do not have other pancreatic diseases.

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
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female at least 30 years of age
  • Able to read, understand, and sign informed consent
  • Patients with a negligible smoking history (defined as no smoking for the past 7 years, and a total smoking history ≤ 5 pack-years) OR patients with AT LEAST a 20 pack-year smoking history

排除标准

  • Patients with a prior diagnosis of pancreatic insufficiency
  • Patients who have a current or remote history of acute or chronic pancreatitis or any other primary pancreatic disease or malignancy
  • Patients who have had pancreatic surgery
  • Patients with a diagnosis of small bowel malabsorption or Celiac disease
  • Patients with any other significant systemic disease that is deemed by the investigator as possibly interfering with the conduct or interpretation of the study

结局指标

主要结局

pancreatic insufficency

时间窗: 1-2 weeks after provision of stool specimen

The primary outcome is presence or absence of pancreatic insufficiency as determined by fecal elastase-1 measurement

次要结局

未报告次要终点

研究者

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

Field Willingham MD

Director of Endoscopy

Emory University

研究点 (1)

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