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
Secondary identifying numbers N/A
Submission date
22/09/2005
Registration date
21/11/2005
Last edited
01/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleComparison of duodenum-preserving pancreatic head resection after Frey and after Berner as treatment of chronic pancreatitis
Study acronymFrey-Berner
Study objectivesBoth 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) studiedChronic pancreatitis
InterventionTwo surgical procedures in comparison - duodenum-preserving pancreatic head resection after Berner and after Frey.
Intervention typeOther
Primary outcome measureQuality of life
Secondary outcome measures1. Local complications
2. Mortality
3. Morbidity
4. Exocrine and endocrine pancreatic function
Overall study start date01/03/2005
Completion date01/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants66 patients - 33/group
Key inclusion criteria1. 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 criteria1. 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 enrolment01/03/2005
Date of final enrolment01/08/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

Department of Surgery, Clinic II
Leipzig
04103
Germany

Sponsor information

University of Leipzig (Germany)
University/education

Liebigstraße 20
Department of Surgery II
Leipzig
04103
Germany

Phone +49 (0)341/9717221
Email with@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

Study outputs

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

Editorial Notes

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