Exocrine Pancreatic Function Testing in Cystic Fibrosis
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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 |
Duodenal juice Serum, full Blood Saliva
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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 |
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.
Contacts and Locations| Contact: Georg Dimcevski, MD, PhD | 55972903 | georg.dimcevski@helse-bergen.no |
| Contact: Trond Engjom, MD | 55975000 | trond.engjom@heløse-bergen.no |
| 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 | |
| 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: | August 24, 2012 |
| 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 Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013