Comparison of duodenum-preserving pancreatic head resection after Frey and after Berner as treatment of chronic pancreatitis

ISRCTN	ISRCTN26157183
DOI	https://doi.org/10.1186/ISRCTN26157183
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

Plain English summary of protocol

Not provided at time of registration

Prof Helmut Witzigmann
Scientific

Department of Surgery, Clinic II
Liebigstr. 20
Leipzig
04103
Germany

Phone	+49 (0)341/9717221
Email	with@medizin.uni-leipzig.de

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Comparison of duodenum-preserving pancreatic head resection after Frey and after Berner as treatment of chronic pancreatitis
Study acronym	Frey-Berner
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic pancreatitis
Intervention	Two surgical procedures in comparison - duodenum-preserving pancreatic head resection after Berner and after Frey.
Intervention type	Other
Primary outcome measure(s)	Quality of life
Key secondary outcome measure(s)	1. Local complications 2. Mortality 3. Morbidity 4. Exocrine and endocrine pancreatic function
Completion date	01/08/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	66
Key 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
Key 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
Date of first enrolment	01/03/2005
Date of final enrolment	01/08/2007

Department of Surgery, Clinic II

Leipzig
04103
Germany

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results		16/04/2008	01/09/2021	No	No

01/09/2021: Added link to meeting abstract.