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
|
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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 |

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 |

Group/Cohort | Intervention/treatment |
---|---|
Patients
Patients with suspected Chronic Pancreatitis
|
Other: diagnostic test |
Control group
Healthy controls
|
Other: diagnostic test |
- Development of pancreatic insufficiency [ Time Frame: 5 years ]
- Peak enzyme Concentration IE [ Time Frame: 5 Years ]
- development of diabetes [ Time Frame: 5 years ]
- Development of pain [ Time Frame: 5 years ]
- weight loss [ Time Frame: 5 years ]
- peak amylase [ Time Frame: 5 Years ]
- lipase peak IE [ Time Frame: 5 Years ]
- Classical score US [ Time Frame: 5 Years ]
- Rosemont score US [ Time Frame: 5 Years ]
Biospecimen Retention: Samples With DNA

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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 |
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.

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
Contact: Georg Dimcevski, M.D | 55972903 | dgeo@helse-bergen.no | |
Contact: Gilja Odd Helge, Professor | 55975000 | odhg@helse-bergen.no |
Norway | |
Haukeland University Hospital | Recruiting |
Bergen, Norway, 5021 | |
Contact: Georg Dimcevski 55972903 dgeo@helse-bergen.no | |
Principal Investigator: Georg Dimcevski, MD |
Principal Investigator: | Georg Dimcevski, PhD | Haukeland University Hospital |
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 |