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

NCT ID: NCT06126601

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-18
• Study Completion Date: 2026-07-31

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.

Conditions

Pancreatectomy; Hyperamylasemia; Pancreatitis, Acute

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marius Distler, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Dresden

Locations

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

Dresden, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Olga Radulova-Mauersberger, Dr. med.

Role: CONTACT

studienzentrum-vtg@ukdd.de

+49 351 458-0

Facility Contacts

Olga Radulova-Mauersberger, Dr. med.

Role: primary

studienzentrum-vtg@ukdd.de

Other Identifiers

DRKS00031860

Identifier Type: OTHER

Identifier Source: secondary_id

VTG-14

Identifier Type: -

Identifier Source: org_study_id