Exocrine Pancreatic Function Testing in Cystic Fibrosis
Recruitment status was Recruiting
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.
|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|
- peak lipase IE [ Time Frame: one year ] [ Designated as safety issue: No ]
- enzyme production [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- emzyme production [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Duodenal juice Serum, full Blood Saliva
|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)|
|Cystic fibrosis patients|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446861
|Contact: Georg Dimcevski, MD, PhDfirstname.lastname@example.org|
|Contact: Trond Engjom, MD||55975000||trond.engjom@heløse-bergen.no|
|Haukeland University Hospital||Recruiting|
|Bergen, Norway, 5020|
|Contact: Georg Dimcevski, MD, PhD 55972903 email@example.com|
|Principal Investigator: Georg Dimcevski, Md, PhD|
|Principal Investigator:||Georg Dimcevski, MD, PhD||Haukeland University Hospital|
|Study Director:||Odd H Gilja, Professor||Haukeland University Hospital|