The Diagnosis of Chronic Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2013 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: July 7, 2013

Last verified: July 2013

History of Changes

Purpose

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.

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: 3 years ] [ Designated as safety issue: No ]
Peak enzyme Concentration IE [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

development of diabetes [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Development of pain [ Time Frame: 3 years ] [ Designated as safety issue: No ]
weight loss [ Time Frame: 3 years ] [ Designated as safety issue: No ]
peak amylase [ Time Frame: one year ] [ Designated as safety issue: No ]

Other Outcome Measures:

lipase peak IE [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Pankreatic juice Duodenal tissue Blood


Estimated Enrollment:	30
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	August 2014 (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

Eligibility


Ages Eligible for Study:	18 Years to 67 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/Cambridge diagnostic criteria will be used.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

No publications provided


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:	July 7, 2013
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 March 03, 2015

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