Hyperamylasemia, Pancreatectomy, Pancreatitis, Acute
Conditions
Brief summary
Recent evidence suggests that postoperative hyperamylasemia (POH) is a predictor of morbidity after pancreatectomy. This is based on the assumption that pancreatitis after pancreatectomy (PPAP) is a major trigger for the development of complications and is indicated by hyperamylasemia. Standardized prospective analysis and correlation with other laboratory parameters, hasn't been performed to date. Therefore the overall study aims are: * To prospectively evaluate the incidence and assess the clinical value of biochemical changes for the postoperative course. * To confirm and improve the definition and classification of postpancreatectomy acute pancreatitis (PPAP) of the International Study Group of Pancreatic Surgery (ISGPS) and to provide knowledge for effective early management of complications.
Interventions
OTHERPancreatectomy
Patients who underwent pancreatectomy will be enrolled. Serum amylase and lipase will be measured preoperatively. During surgery, blood samples will be taken after completing the pancreatic anastomosis and at the end of the operation during skin suture. Patients will be followed up during hospital stay, 3 and 6 months after discharge. The clinical outcome (complications, rescue pancreatectomy) will be recorded and analysed. Postoperative blood samples, according to clinical standard, will be taken at the 1, 2, 3, 5 and 7 day postoperatively. In addition to amylase several more parameters will be examined intra- and postoperatively: leucocytes, lipase, CRP, bilirubin, transaminases, AP, GGT, creatinine, interleukin-6, PCT. Intraoperative 1-2ml of pancreas juice will be taken for the evaluation of amylase and lipase levels.
Sponsors
Technische Universität Dresden
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* All patients undergoing pancreatic resection for malignant and benign disease with or without pancreatic anastomosis * Patients aged 18-85 years * Willingness to participate as demonstrated by giving a written informed consent.
Exclusion criteria
* Necrosectomy (endoscopic or open) for primary acute pancreatitis or within laparotomy * Age less than 18 years * Surgical drainage procedures without pancreatic resection (cystojejunostomy for pancreatic pseudocysts) * One-stage total pancreatectomy * Missing written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PPAP (Postpancreatectomy Acute Pancreatitis) | 90 days after surgery | Incidence after pancreasresection (pancreatoduodenectomy and distal pancreas resection) according to the definition of ISGPS (International Study Group on Pancreatic Surgery) |
| Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia) | 90 days after surgery | Correlation with postoperative complications according to the Clavien-Dindo classification and Comprehensive Complication Index ( CCI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy | 90 days after surgery | Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia |
| Correlation between hyperamylasemia and radiological findings for pancreatitis | 90 days after surgery | Incidence of pancreatitis according to the CT scan postoperatively |
| Incidence of postoperative mortality | 90 days after surgery | Postoperative death after complications |
Countries
Germany
Contacts
CONTACTOlga Radulova-Mauersberger, Dr. med.
PRINCIPAL_INVESTIGATORMarius Distler, Prof. Dr.
University Hospital Dresden
Outcome results
None listed