An observational study in Pancreatectomy, Hyperamylasemia and Pancreatitis, Acute, sponsored by Technische Universität Dresden. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Technische Universität Dresden · Observational
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:
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 192 observational studies indexed under Pancreatitis.
Browse Pancreatitis studies →Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients undergoing a pancreatic resection
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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)
Time frame: 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)
Time frame: 90 days after surgery
Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy
Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia
Time frame: 90 days after surgery
Correlation between hyperamylasemia and radiological findings for pancreatitis
Incidence of pancreatitis according to the CT scan postoperatively
Time frame: 90 days after surgery
Incidence of postoperative mortality
Postoperative death after complications
Time frame: 90 days after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Dec 2026, 41 months after the start.
Of 82 non-industry observational studies under Pancreatitis, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 133. This study's planned 41 months is below that.
Counting every sponsor, half of 86 studies reached it within 50 months; a quarter within 21 and three quarters within 133.
How these figures are worked out, and which studies are left out of them.
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