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Pancreatic Insufficiency Secondary to Tobacco Exposure

Pancreatic Insufficiency Secondary to Tobacco Exposure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01988350
Enrollment
202
Registered
2013-11-20
Start date
2013-05-31
Completion date
2013-08-31
Last updated
2013-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Insufficiency

Keywords

pancreatic insufficiency, pancreatic elastase, fecal elastase, smoking, tobacco

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.

Interventions

None listed

Sponsors

Emory University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pancreatic insufficency1-2 weeks after provision of stool specimenThe primary outcome is presence or absence of pancreatic insufficiency as determined by fecal elastase-1 measurement

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026