Combined retrospective/prospective epidemiological trial
ISRCTN | ISRCTN85868389 |
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DOI | https://doi.org/10.1186/ISRCTN85868389 |
Secondary identifying numbers | N/A |
- Submission date
- 22/09/2005
- Registration date
- 23/02/2006
- Last edited
- 05/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Volker Keim
Scientific
Scientific
Ph.-Rosenthalstr. 27
Medical Department II Gastroenterology
Leipzig
04103
Germany
Phone | +49 (0)341 9712233 |
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keimv@medizin.uni-leipzig.de |
Study information
Study design | Combined retrospective/prospective epidemiological trial |
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Primary study design | Observational |
Secondary study design | Other |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study acronym | Pankcourse |
Study objectives | 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(s) | Ethics committee of Leipzig University (ref: 160/2004) |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/05/2001 |
Completion date | 01/05/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 200 patients with non-alcoholic, 100 with alcoholic pancreatitis |
Key inclusion criteria | Patients with chronic pancreatitis with written informed consent |
Key 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 |
Date of first enrolment | 01/05/2001 |
Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- Germany
Study participating centre
Ph.-Rosenthalstr. 27
Leipzig
04103
Germany
04103
Germany
Sponsor information
University of Leipzig (Germany)
University/education
University/education
Ph.-Rosenthalstr. 27
Medical Department II Gastroenterology
Leipzig
04103
Germany
Phone | +49 (0)341 9712233 |
---|---|
keimv@medizin.uni-leipzig.de | |
https://ror.org/03s7gtk40 |
Funders
Funder type
University/education
University of Leipzig (Germany)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |