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Exocrine Pancreatic Function Testing in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01446861
Recruitment Status : Unknown
Verified August 2016 by Haukeland University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 5, 2011
Last Update Posted : August 24, 2016
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:

Purpose The purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function (EPF). The investigators will be testing exocrine pancreatic function in patients with cystic fibrosis (CF). Exocrine pancreatic function and imaging will be correlated to age group, genotype, nutritional status and quality of life. Earlier detection of exocrine pancreatic failure in the non classical form of cystic fibrosis may be of therapeutically benefit.

Hypotheses Endoscopic short test can be applied in diagnosing and monitoring exocrine pancreatic function in patients with cystic fibrosis.

New functional testing of exocrine pancreatic function is superior to traditional testing with fecal elastase.

MRI and ultrasound methods can give volume output estimate in cystic fibrosis patients.

Contrast enhanced ultrasound can quantify reduced or delayed pancreatic perfusion and parenchymal changes in cystic fibrosis patients.

Elastography/ CEUS can be used in prediction and monitoring of fibrosis development and development of hepatocellular carcinoma in the liver of cystic fibrosis patients.

Immunohistochemical quantification of secretin/ cholecystokinin (CCK) producing cell in duodenum can be utilized as a model hormonal signaling in cystic fibrosis patients with exocrine pancreatic function.

Condition or disease
Cystic Fibrosis

Detailed Description:

Study design: Observational, cohort studies.

Patient characterization: Age, gender, and Genetic status from electronical records.

Exocrine function testing (EPF): Secretin stimulated ultrasound and short endoscopic secretin test (EST). Faecal Elastase.

Imaging: Transabdominal ultrasound of the liver and pancreas. secretin stimulated MRI. Contrast enhanced ultrasound (CEUS) of the pancreas using SonoVue contrast.


Study 1: Exocrine pancreatic function by duodenal bicarbonate/ Enzymes related to Genetics and F elastase.

Study 2: Ultrasound parenchymal changes of the pancreas related to Genetics and EPF.

Study 3/4: Pancreatic secretion by ultrasound, MRI and EST related to EPF Study 5; Perfusion of the pancreas by CEUS related to EPF

Study 6: Genotype-phenotype conciderations of the CF pancreas.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Pancreatic Failure in Patients With Cystic Fibrosis A Multimodal Study of Exocrine Pancreatic Failure in Cystic Fibrosis
Study Start Date : January 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Cystic fibrosis patients
Consecutive cystic fibrosis patients attending regular Controls at the CF clinic in Bergen
Healthy controls
Age and gender matchet healthy Controls recruited by Board notice and advertising.

Primary Outcome Measures :
  1. peak lipase IE [ Time Frame: one year ]

Secondary Outcome Measures :
  1. enzyme production [ Time Frame: 2 years ]

Other Outcome Measures:
  1. emzyme production [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Duodenal juice Serum, full Blood Saliva

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Cystic fibrosis patients over the age of 15 years Healthy controls between 18 and 67 years

Inclusion Criteria:

  • Diagnosis cystic fibrosis. Age over 15 years. Assigned to routine control at department of lung diseases, Haukeland university hospital.

Exclusion Criteria:

  • Unable to concent, allergies to Sonovue ultrasound contrast, pregnant or breastfeeding, contraindications against endoscopy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01446861

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Haukeland University Hospital
Bergen, Norway, 5020
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
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Principal Investigator: Georg Dimcevski, MD, PhD Haukeland University Hospital
Study Director: Odd H Gilja, Professor Haukeland University Hospital

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Responsible Party: Haukeland University Hospital Identifier: NCT01446861     History of Changes
Other Study ID Numbers: 2010/2857-7
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be published in peer rewieved journals
Keywords provided by Haukeland University Hospital:
Cystic fibrosis
Exocrine function
Contrast ultrasound
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases