Condition category
Digestive System
Date applied
22/09/2005
Date assigned
23/02/2006
Last edited
05/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes