Combined retrospective/prospective epidemiological trial

ISRCTN ISRCTN85868389
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

Ph.-Rosenthalstr. 27
Medical Department II Gastroenterology
Leipzig
04103
Germany

Phone +49 (0)341 9712233
Email keimv@medizin.uni-leipzig.de

Study information

Study designCombined retrospective/prospective epidemiological trial
Primary study designObservational
Secondary study designOther
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymPankcourse
Study objectivesThe 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) studiedChronic pancreatitis
InterventionCombined retrospective/prospective epidemiological trial with retrospective and five-year prospective observation using questionnaires on symptoms concerning chronic pancreatitis
Intervention typeOther
Primary outcome measureCourse of disease
Secondary outcome measures1. 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 date01/05/2001
Completion date01/05/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200 patients with non-alcoholic, 100 with alcoholic pancreatitis
Key inclusion criteriaPatients with chronic pancreatitis with written informed consent
Key exclusion criteria1. 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 enrolment01/05/2001
Date of final enrolment01/05/2004

Locations

Countries of recruitment

  • Germany

Study participating centre

Ph.-Rosenthalstr. 27
Leipzig
04103
Germany

Sponsor information

University of Leipzig (Germany)
University/education

Ph.-Rosenthalstr. 27
Medical Department II Gastroenterology
Leipzig
04103
Germany

Phone +49 (0)341 9712233
Email keimv@medizin.uni-leipzig.de
ROR logo "ROR" https://ror.org/03s7gtk40

Funders

Funder type

University/education

University of Leipzig (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan