RecruitingNCT06126601

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

Sponsor

Technische Universität Dresden

Enrollment

150 participants

Start Date

Jul 18, 2023

Study Type

OBSERVATIONAL

Conditions

Pancreatectomy Pancreatitis, Acute Hyperamylasemia

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria3

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 Criteria5

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

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

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.