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RECRUITING
NCT06126601

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

Sponsor: Technische Universität Dresden

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2023-07-18

Completion Date

2026-07

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

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.

Locations (1)

University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery

Dresden, Germany