The Diagnosis of Chronic Pancreatitis
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2016 by Haukeland University Hospital
Sponsor:
Haukeland University Hospital
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: August 17, 2016
Last verified: August 2016
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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:
Genetics Home Reference related topics:
hereditary pancreatitis
MedlinePlus related topics:
Pancreatitis
U.S. FDA Resources
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 (Child, Adult, Senior) |
| 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
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: | August 17, 2016 |
| 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 Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on September 23, 2016