Pancreatic Insufficiency Secondary to Tobacco Exposure | NCT01988350

Studies
Pancreatic Insufficiency Secondary to Tobacco Exposure

NCT01988350

Sponsor

Emory University

Status

Completed

Last Update Posted

Nov 20, 2013Estimated

Enrollment

202Actual

Phase

Not provided

Conditions

Pancreatic Insufficiency

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Jul 24, 2013

First Submission Date that Met QC Criteria

Nov 13, 2013

First Posted Date

Nov 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2013

Last Update Posted Date

Nov 20, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

202Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pancreatic insufficency	The primary outcome is presence or absence of pancreatic insufficiency as determined by fecal elastase-1 measurement	1-2 weeks after provision of stool specimen

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Smokers and non-smoking controls without a h/o pancreatic disease.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Field F Willingham, MD, MPH	Emory University School of Medicine, Division of Gastroenterology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Emory Clinic		Atlanta	Georgia	30322	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27846134	Derived	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.

ID	Term
D010188	Exocrine Pancreatic Insufficiency
D012907	Smoking

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D001519	Behavior