Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06126601

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pancreatectomy Digestive System Diseases Hyperamylasemia Pancreatic Diseases Pancreatitis Pancreatitis, Acute Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Dresden, 01307, Germany

Location status: Recruiting

Location contact

Olga Radulova-Mauersberger, Dr. med.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of PPAP (Postpancreatectomy Acute Pancreatitis)

    Time frame: 90 days after surgery

    Incidence after pancreasresection (pancreatoduodenectomy and distal pancreas resection) according to the definition of ISGPS (International Study Group on Pancreatic Surgery)

  2. Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia)

    Time frame: 90 days after surgery

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

Secondary outcomes

  1. Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy

    Time frame: 90 days after surgery

    Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia

  2. Correlation between hyperamylasemia and radiological findings for pancreatitis

    Time frame: 90 days after surgery

    Incidence of pancreatitis according to the CT scan postoperatively

  3. Incidence of postoperative mortality

    Time frame: 90 days after surgery

    Postoperative death after complications

Study contacts

Contact information is provided by the study sponsor or research team.

Olga Radulova-Mauersberger, Dr. med.

CONTACT

[email protected]

+49 351 458-0

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Acronym: HYPPO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.