Exocrine Pancreatic Function Testing in Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Haukeland University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01446861
First received: October 4, 2011
Last updated: July 8, 2013
Last verified: June 2012
  Purpose

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
Cystic Fibrosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • peak lipase IE [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • enzyme production [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • emzyme production [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Duodenal juice Serum, full Blood Saliva


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cystic fibrosis patients
Healthy controls

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446861

Contacts
Contact: Georg Dimcevski, MD, PhD 55972903 georg.dimcevski@helse-bergen.no
Contact: Trond Engjom, MD 55975000 trond.engjom@heløse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5020
Contact: Georg Dimcevski, MD, PhD    55972903    georg.dimcevski@helse-bergen.no   
Principal Investigator: Georg Dimcevski, Md, PhD         
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Investigators
Principal Investigator: Georg Dimcevski, MD, PhD Haukeland University Hospital
Study Director: Odd H Gilja, Professor Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01446861     History of Changes
Other Study ID Numbers: 2010/2857-7
Study First Received: October 4, 2011
Last Updated: July 8, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
Cystic fibrosis
Pancreas
Exocrine function
Ultrasound
Contrast ultrasound

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014