Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety

Study Overview
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Brief Summary
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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.

Official Title
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Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety

Conditions
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Pancreatitis, Acute, Pancreatectomy, Hyperamylasemia

Intervention / Treatment
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* Other: Pancreatectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Pancreatectomy|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 90 days after surgery | 
| Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia) | Correlation with postoperative complications according to the Clavien-Dindo classification and Comprehensive Complication Index ( CCI) | 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy | Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia | 90 days after surgery | 
| Correlation between hyperamylasemia and radiological findings for pancreatitis | Incidence of pancreatitis according to the CT scan postoperatively | 90 days after surgery | 
| Incidence of postoperative mortality | Postoperative death after complications | 90 days after surgery |