Comparison of duodenum-preserving pancreatic head resection after Frey and after Berner as treatment of chronic pancreatitis
ISRCTN | ISRCTN26157183 |
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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
Scientific
Department of Surgery, Clinic II
Liebigstr. 20
Leipzig
04103
Germany
Phone | +49 (0)341/9717221 |
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with@medizin.uni-leipzig.de |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | Quality of life |
Secondary outcome measures | 1. Local complications 2. Mortality 3. Morbidity 4. Exocrine and endocrine pancreatic function |
Overall study start date | 01/03/2005 |
Completion date | 01/08/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 66 patients - 33/group |
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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Surgery, Clinic II
Leipzig
04103
Germany
04103
Germany
Sponsor information
University of Leipzig (Germany)
University/education
University/education
Liebigstraße 20
Department of Surgery II
Leipzig
04103
Germany
Phone | +49 (0)341/9717221 |
---|---|
with@medizin.uni-leipzig.de | |
https://ror.org/03s7gtk40 |
Funders
Funder type
University/education
University of Leipzig (Germany)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.