Pancreatic Insufficiency Secondary to Tobacco Exposure

Completed

• Conditions: Pancreatic Insufficiency

• Registration Number: NCT01988350
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-24
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-13
• Last Update Submitted: 2013-11-13
• Study First Posted: 2013-11-20
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

1. Male or female at least 30 years of age
2. Able to read, understand, and sign informed consent
3. 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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pancreatic insufficency	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

Trial Locations

Locations (1)

The Emory Clinic; 🇺🇸 Atlanta, Georgia, United States