Pancreatic Insufficiency Secondary to Tobacco Exposure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Pancreatic Insufficiency

Keywords

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pancreatic insufficiency pancreatic elastase fecal elastase smoking tobacco

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-smokers

No interventions assigned to this group

Smokers

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Field Willingham MD

Director of Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Field F Willingham, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University School of Medicine, Division of Gastroenterology

Locations

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The Emory Clinic

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 27846134 (View on PubMed)

Other Identifiers

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IRB00064360

Identifier Type: -

Identifier Source: org_study_id