Pancreatic Insufficiency Secondary to Tobacco Exposure
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
- 是
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
Field Willingham MD
Director of Endoscopy
Emory University
