The Diagnosis of Chronic Pancreatitis

NCT01059669 | Unknown

• 1 other identifier: REK nr 241.08
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis

Keywords

Chronic pancreatitis; Pain; Exocrine insufficiency; Diabetes; Nutrition; Ultrasound

Outcome Measures

Primary Outcomes (2)

• Development of pancreatic insufficiency

  5 years

• Peak enzyme Concentration IE

  5 Years

Secondary Outcomes (4)

• development of diabetes

  5 years

• Development of pain

  5 years

• weight loss

  5 years

• peak amylase

  5 Years

Other Outcomes (3)

• lipase peak IE

  5 Years

• Classical score US

  5 Years

• Rosemont score US

  5 Years

Study Arms (2)

Patients

Patients with suspected Chronic Pancreatitis

Other: diagnostic test

Control group

Healthy controls

Other: diagnostic test

Interventions

diagnostic test OTHER

Control group; Patients

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with suspected chronic pancreatitis age 18-67 years

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Pankreatic juice Duodenal tissue Blood

MeSH Terms

Conditions

Pancreatitis, Chronic; Pain; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Georg Dimcevski, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georg Dimcevski, M.D

CONTACT

55972903; dgeo@helse-bergen.no

Gilja Odd Helge, Professor

CONTACT

55975000; odhg@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: February 1, 2010
• Study Start: August 1, 2009
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 18, 2016

Record last verified: 2016-08

Locations

NO (1)