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

NCT06126601 | Recruiting

• 2 other identifiers: VTG-14DRKS00031860
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

  90 days after surgery

• Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia)

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

  90 days after surgery

Secondary Outcomes (3)

• Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy

  90 days after surgery

• Correlation between hyperamylasemia and radiological findings for pancreatitis

  90 days after surgery

• Incidence of postoperative mortality

  90 days after surgery

Interventions

Pancreatectomy OTHER

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients undergoing a pancreatic resection

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

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

Dresden, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Hyperamylasemia; Pancreatitis

Interventions

Pancreatectomy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Marius Distler, Prof. Dr.

  University Hospital Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Radulova-Mauersberger, Dr. med.

CONTACT

+49 351 458-0; studienzentrum-vtg@ukdd.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: November 13, 2023
• Study Start: July 18, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)