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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorTechnische Universität Dresden

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Pancreatectomy

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
90 days after surgery
2

Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia)

Correlation with postoperative complications according to the Clavien-Dindo classification and Comprehensive Complication Index ( CCI)

Time frame
90 days after surgery

Secondary outcomes

1

Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy

Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia

Time frame
90 days after surgery
2

Correlation between hyperamylasemia and radiological findings for pancreatitis

Incidence of pancreatitis according to the CT scan postoperatively

Time frame
90 days after surgery
3

Incidence of postoperative mortality

Postoperative death after complications

Time frame
90 days after surgery

Other outcomes

Sponsors and contacts

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