Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pancreatectomy.
- Who it may be relevant to
- Registry conditions: Pancreatectomy, Hyperamylasemia, Pancreatitis, Acute. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 ta
Primary outcome measures
- Incidence of PPAP (Postpancreatectomy Acute Pancreatitis) [Time frame: 90 days after surgery]
- Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia) [Time frame: 90 days after surgery]
Secondary outcome measures (3)
- Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy [Time frame: 90 days after surgery]
- Correlation between hyperamylasemia and radiological findings for pancreatitis [Time frame: 90 days after surgery]
- Incidence of postoperative mortality [Time frame: 90 days after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 1 center
- University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery — Dresden
Identifiers
NCT: NCT06126601 · VTG-14 · DRKS00031860