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

Recruiting

• Conditions: Pancreatitis, Acute; Pancreatectomy; Hyperamylasemia

• Registration Number: NCT06126601
• Lead Sponsor: Technische Universität Dresden

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-18
• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2026-01
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia)	90 days after surgery	Correlation with postoperative complications according to the Clavien-Dindo classification and Comprehensive Complication Index ( CCI)
Incidence of PPAP (Postpancreatectomy Acute Pancreatitis)	90 days after surgery	Incidence after pancreasresection (pancreatoduodenectomy and distal pancreas resection) according to the definition of ISGPS (International Study Group on Pancreatic Surgery)

Secondary Outcome Measures

Name	Time	Method
Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy	90 days after surgery	Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia
Incidence of postoperative mortality	90 days after surgery	Postoperative death after complications
Correlation between hyperamylasemia and radiological findings for pancreatitis	90 days after surgery	Incidence of pancreatitis according to the CT scan postoperatively

Trial Locations

Locations (1)

University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery; 🇩🇪 Dresden, Germany