The Diagnosis of Chronic Pancreatitis
This study is currently recruiting participants.
Verified June 2012 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: June 1, 2012
Last verified: June 2012
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | January 29, 2010 | ||||||||
| Last Updated Date | June 1, 2012 | ||||||||
| Start Date ICMJE | August 2009 | ||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Development of pancreatic insufficiency [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01059669 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Diagnosis of Chronic Pancreatitis | ||||||||
| Official Title ICMJE | A Multimodal Approach to Diagnose Patients With Chronic Pancreatitis | ||||||||
| Brief Summary | To develop a new standardized multimodal diagnostic approach to CP considering fat in faeces, imaging 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 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Pankreatic juice Duodenal tissue Blood |
||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patient with suspected chronic pancreatitis age 18-67 years |
||||||||
| Condition ICMJE | Chronic Pancreatitis | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | August 2015 | ||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 67 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01059669 | ||||||||
| Other Study ID Numbers ICMJE | REK nr 241.08 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Georg Gjorgji Dimcevski, Haukeland University Hospital | ||||||||
| Study Sponsor ICMJE | Haukeland University Hospital | ||||||||
| Collaborators ICMJE | University of Bergen | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Haukeland University Hospital | ||||||||
| Verification Date | June 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||