Clinical trial NCT01988350: Pancreatic Insufficiency Secondary to Tobacco Exposure
Official title: Pancreatic Insufficiency Secondary to Tobacco Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Insufficiency
Keywords: pancreatic insufficiency
pancreatic elastase
fecal elastase
smoking
tobacco
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 202
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Smokers and non-smoking controls without a h/o pancreatic disease.

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: pancreatic insufficency
timeFrame: 1-2 weeks after provision of stool specimen
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
Study officials:
affiliation: Emory University School of Medicine, Division of Gastroenterology
name: Field F Willingham, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raphael KL, Chawla S, Kim S, Keith CG, Propp DR, Chen ZN, Woods KE, Keilin SA, Cai Q, Willingham FF. Pancreatic Insufficiency Secondary to Tobacco Exposure: A Controlled Cross-Sectional Evaluation. Pancreas. 2017 Feb;46(2):237-243. doi: 10.1097/MPA.0000000000000721.