Contact information
Type
Scientific
Primary contact
Prof Volker Keim
ORCID ID
Contact details
Ph.-Rosenthalstr. 27
Medical Department II Gastroenterology
Leipzig
04103
Germany
+49 (0)341 9712233
keimv@medizin.uni-leipzig.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Pankcourse
Study hypothesis
The course of the disease (symptoms, progression) in patients with chronic pancreatitis seems to depend on the etiology of disease. The trial observes and compares different entities of chronic pancreatitis especially concerning alcoholic and non-alcoholic development but also with stratification after different genetic mutations.
Ethics approval
Ethics committee of Leipzig University (ref: 160/2004)
Study design
Combined retrospective/prospective epidemiological trial
Primary study design
Observational
Secondary study design
Other
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Chronic pancreatitis
Intervention
Combined retrospective/prospective epidemiological trial with retrospective and five-year prospective observation using questionnaires on symptoms concerning chronic pancreatitis
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Course of disease
Secondary outcome measures
1. Age of first manifestation
2. Calcification at first manifestation
3. Time until development of endocrine and exocrine dysfunction
4. Pain and inflammatory episodes
5. Development of complication as pancreatic duct stenosis
Overall trial start date
01/05/2001
Overall trial end date
01/05/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with chronic pancreatitis with written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200 patients with non-alcoholic, 100 with alcoholic pancreatitis
Participant exclusion criteria
1. Uncured cancer within last five years
2. Radiation and chemotherapy within last five years
3. Other disorders causing abdominal pain such as chronic inflammatory bowel disease, irritable bowel disease and chronic ulcer disease
Recruitment start date
01/05/2001
Recruitment end date
01/05/2004
Locations
Countries of recruitment
Germany
Trial participating centre
Ph.-Rosenthalstr. 27
Leipzig
04103
Germany
Sponsor information
Organisation
University of Leipzig (Germany)
Sponsor details
Ph.-Rosenthalstr. 27
Medical Department II Gastroenterology
Leipzig
04103
Germany
+49 (0)341 9712233
keimv@medizin.uni-leipzig.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Leipzig (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary