Exocrine Pancreatic Function Testing in Cystic Fibrosis

NCT01446861 | Unknown

• 1 other identifier: 2010/2857-7
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; Pancreas; Exocrine function; Ultrasound; Contrast ultrasound

Outcome Measures

Primary Outcomes (1)

• peak lipase IE

  one year

Secondary Outcomes (1)

• enzyme production

  2 years

Other Outcomes (1)

• emzyme production

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cystic fibrosis patients over the age of 15 years Healthy controls between 18 and 67 years

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5020, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Duodenal juice Serum, full Blood Saliva

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Georg Dimcevski, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Odd H Gilja, Professor

  Haukeland University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 5, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 24, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)