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The Diagnosis of Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT01059669
Recruitment Status : Recruiting
First Posted : February 1, 2010
Last Update Posted : August 18, 2016
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Georg Gjorgji Dimcevski, Haukeland University Hospital

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment
Chronic Pancreatitis Other: diagnostic test

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Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Multimodal Approach to Diagnose Patients With Chronic Pancreatitis
Study Start Date : August 2009
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patients
Patients with suspected Chronic Pancreatitis
 Other: diagnostic test
Control group
Healthy controls
 Other: diagnostic test


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Development of pancreatic insufficiency [ Time Frame: 5 years ]
  2. Peak enzyme Concentration IE [ Time Frame: 5 Years ]

Secondary Outcome Measures :
  1. development of diabetes [ Time Frame: 5 years ]
  2. Development of pain [ Time Frame: 5 years ]
  3. weight loss [ Time Frame: 5 years ]
  4. peak amylase [ Time Frame: 5 Years ]

Other Outcome Measures:
  1. lipase peak IE [ Time Frame: 5 Years ]
  2. Classical score US [ Time Frame: 5 Years ]
  3. Rosemont score US [ Time Frame: 5 Years ]

Biospecimen Retention:   Samples With DNA
Pankreatic juice Duodenal tissue Blood

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016

Keywords provided by Georg Gjorgji Dimcevski, Haukeland University Hospital:
Chronic pancreatitis
Pain
Exocrine insufficiency
 Diabetes
Nutrition
Ultrasound

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