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

Pancreatitis, Acute Clinical Trial

— HYPPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06126601
• Other study ID #: VTG-14
• Secondary ID: DRKS00031860
• Status: Recruiting
• Start date: July 18, 2023
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: Technische Universität Dresden
• Contact: Olga Radulova-Mauersberger, Dr. med.
• Phone: +49 351 458-0
• Email: studienzentrum-vtg[@]ukdd.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatectomy
• Pancreatitis
• Pancreatitis, Acute

Intervention

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

Country	Name	City	State
Germany	University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy	Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia	90 days after surgery
Secondary	Correlation between hyperamylasemia and radiological findings for pancreatitis	Incidence of pancreatitis according to the CT scan postoperatively	90 days after surgery
Secondary	Incidence of postoperative mortality	Postoperative death after complications	90 days after surgery