Combined retrospective/prospective epidemiological trial

ISRCTN	ISRCTN85868389
DOI	https://doi.org/10.1186/ISRCTN85868389
Protocol serial number	N/A
Sponsor	University of Leipzig (Germany)
Funder	University of Leipzig (Germany)

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

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

Primary study design	Observational
Study design	Combined retrospective/prospective epidemiological trial
Secondary study design	Other
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(s)	Course of disease
Key secondary outcome measure(s)	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
Completion date	01/05/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	300
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

Ph.-Rosenthalstr. 27

Leipzig
04103
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan