The Diagnosis of Chronic Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Haukeland University Hospital
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Georg Gjorgji Dimcevski, Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01059669
First received: January 29, 2010
Last updated: December 18, 2015
Last verified: December 2015
  Purpose

To develop a new standardized multimodal diagnostic approach to CP considering:

WP 1: Fat in faeces and functional testing; the combination of tests has to be easy to practice, should take as little time as possible and discomfort for the patient has to be minimized WP 2: Advanced ultrasonography and imaging modalities. The focus is on validating standard parenchymal, contrast enhanced and functional ultrasound compared to a modern imaging standard. (CT, EUS, MRI)

To evaluate the reliability and feasibility of these novel methods in healthy volunteers; AND

To compare findings in known severe CP patients and different stages of pancreatic insufficiency in patients with CP.


Condition Intervention
Chronic Pancreatitis
Other: diagnostic test

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Multimodal Approach to Diagnose Patients With Chronic Pancreatitis

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Development of pancreatic insufficiency [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Peak enzyme Concentration IE [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • development of diabetes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Development of pain [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • weight loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • peak amylase [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • lipase peak IE [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Classical score US [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Rosemont score US [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Pankreatic juice Duodenal tissue Blood

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients
Patients with suspected Chronic Pancreatitis
Other: diagnostic test
Control group
Healthy controls
Other: diagnostic test

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patient with suspected chronic pancreatitis age 18-67 years
Criteria

Inclusion Criteria:

  • The patients will be included from the Department of Medicine at Haukeland University Hospital in Norway. The Marseille-Rome diagnostic criteria will be used. Patients will be scored according to the Layer score. The symptoms should be unrelated to other systemic diseases.

Exclusion Criteria:

  • Personality disturbances and alcohol consumption 24 hours prior to the study. Any other diseases and drugs associated with malabsorption; pregnancy or lactating women; heart disease or allergy against MR or ultrasound contrast agents.
  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: NCT01059669

Contacts
Contact: Georg Dimcevski, M.D 55972903 dgeo@helse-bergen.no
Contact: Gilja Odd Helge, Professor 55975000 odhg@helse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Georg Dimcevski    55972903    dgeo@helse-bergen.no   
Principal Investigator: Georg Dimcevski, MD         
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Investigators
Principal Investigator: Georg Dimcevski, PhD Haukeland University Hospital
  More Information

Responsible Party: Georg Gjorgji Dimcevski, MD, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01059669     History of Changes
Other Study ID Numbers: REK nr 241.08 
Study First Received: January 29, 2010
Last Updated: December 18, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
Chronic pancreatitis
Pain
Exocrine insufficiency
Diabetes
Nutrition
Ultrasound

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 02, 2016