Contact information
Type
Scientific
Primary contact
Prof Helmut Witzigmann
ORCID ID
Contact details
Department of Surgery
Clinic II
Liebigstr. 20
Leipzig
04103
Germany
+49 (0)341/9717221
with@medizin.uni-leipzig.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Frey-Berner
Study hypothesis
Both surgical procedures are accepted as treatment for patients with chronic pancreatitis and chronic pain. They are both pancreatic tissue preserving in comparison to classic Whipple-procedure. The procedure after Berner is the shorter and less invasive surgical procedure with less resection of pancreatic tissue. Assuming an equal outcome in patients with chronic pancreatitis, the modification of Berner could be the gold standard as the least invasive and tissue resecting procedure.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic pancreatitis
Intervention
Two surgical procedures in comparison - duodenum-preserving pancreatic head resection after Berner and after Frey.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Quality of life
Secondary outcome measures
1. Local complications
2. Mortality
3. Morbidity
4. Exocrine and endocrine pancreatic function
Overall trial start date
01/03/2005
Overall trial end date
01/08/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Chronic pancreatitis
2. Chronic pain greater than 1 year
3. Complications of chronic pancreatitis as duodenal stenosis or treatment resistent pancreatic duct stenosis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
66 patients - 33/group
Participant exclusion criteria
1. Chronic pancreatitis without involvement of pancretic head
2. Hints for malignant pancreas disorders
3. Not cured cancer or chemotherapy or radiation within last 5 years
Recruitment start date
01/03/2005
Recruitment end date
01/08/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Surgery, Clinic II
Leipzig
04103
Germany
Sponsor information
Organisation
University of Leipzig (Germany)
Sponsor details
Liebigstraße 20
Department of Surgery II
Leipzig
04103
Germany
+49 (0)341/9717221
with@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
Basic results (scientific)
Publication list