Exocrine Pancreatic Function Testing in Cystic Fibrosis
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|ClinicalTrials.gov 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
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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Observational Model:||Case Control|
|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|
Cystic fibrosis patients
Consecutive cystic fibrosis patients attending regular Controls at the CF clinic in Bergen
Age and gender matchet healthy Controls recruited by Board notice and advertising.
- peak lipase IE [ Time Frame: one year ]
- enzyme production [ Time Frame: 2 years ]
- emzyme production [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
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 ClinicalTrials.gov identifier (NCT number): NCT01446861
|Haukeland University Hospital|
|Bergen, Norway, 5020|
|Principal Investigator:||Georg Dimcevski, MD, PhD||Haukeland University Hospital|
|Study Director:||Odd H Gilja, Professor||Haukeland University Hospital|