Chronic pancreatitis Digestive System Other Chronic pancreatitis
Conditions
Interventions
Every patient eligible for pancreatic head resection due to chronic pancreatitis will be asked for informed consent and will be thereafter intraoperatively randomised to either Beger's or the Berne mo
Sponsors
University of Heidelberg Medical School (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing elective duodenum-preserving pancreatic head resection due to chronic pancreatitis. Eligibility criteria: 1. Patients of any age (greater than 18 years) 2. Expected survival time more than 24 months 3. Informed consent
Exclusion criteria
Exclusion criteria: 1. Participation in another intervention trial that would interfere with the intervention and outcome of this study 2. Severe psychiatric disorders or neurological diseases 3. Lack of compliance 4. Drug and/or alcohol abuse according to local standards
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is combined out of four components. In order to adjust for multiple testing a hierarchical model is used. 1. Duration of surgical procedure [min] 2. Quality of life (EORTC QLQ-C30 questionnaire and the disease specific module for pancreatic diseases EORTC QLQ-PAN26) at 12 months after the intervention 3. Duration of stay on the intensive care unit 4. Duration of postoperative hospital stay | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequencies of early and late onset complications such as intra- or postoperative bleeding with subsequent need for blood transfusion, pancreatic fistula, postoperative pulmonary complications, wound infections and re-laparotomy; exocrine and endocrine pancreatic function as determined by levels of HbA1c and stool elastase. | — |
Countries
Germany
Outcome results
None listed