About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
All patients undergoing a pancreatic resection
Trial design
Case-only
Prospective
Treatments tested in this trial
Pancreatectomy
Other interventionPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of PPAP (Postpancreatectomy Acute Pancreatitis)
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)
Correlation with postoperative complications according to the Clavien-Dindo classification and Comprehensive Complication Index ( CCI)
Secondary outcomes
Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy
Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia
Correlation between hyperamylasemia and radiological findings for pancreatitis
Incidence of pancreatitis according to the CT scan postoperatively
Incidence of postoperative mortality
Postoperative death after complications
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