5-524: null C25 K86.3 K86.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Age equal or above 18 years -Expected survival time more than 12 month -Patients with at least one of the following pathologic diseases scheduled for elective resection: *Resectable malignancies of pancreatic body and/or tail *Resectable chronic pancreatitis of the body and/or tail *Resectable benigne tumours of the pancreas including neuroendocrine tumours *Resectable pseudocyst of the pancreatic body and/or tail
Exclusion criteria
Exclusion criteria: -Current immunosuppressive therapy -Chemotherapy within 2 weeks before operation -Radiotherapy within 8 weeks before operation -Curative resecion is not feasible -Severe psychiatric or neurologic diseases -Drug- and/or alcohol-abuse according to local standarts -Participation in another intervention trial with interference of intervention or outcome -Inability to follow instructions given by the investigator or interviewer -Expected lack of compliance -Lack of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined primary endpoint: presence of a pancreatic fistula and / or death due to any cause on day 7 postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: operating time, frequency of burst abdomen, wound infection, and intraabdominal fluid collection and abscess, postoperative length of hospital stay, new onset of diabetes mellitus, one-year survival. | — |
Countries
Belgium, Germany, Italy, Netherlands, Slovenia, United Kingdom
Contacts
Studienzentrum der Deutschen Gesellschaft für Chirurgie-SDGC Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universität Heidelberg