NCT06126601 Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety
| NCT ID | NCT06126601 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technische Universität Dresden |
| Condition | Pancreatectomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-07-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-07-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Marius Distler, Prof. Dr.
PRINCIPAL INVESTIGATOR
University Hospital Dresden
Frequently Asked Questions
Who can join the NCT06126601 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Pancreatectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06126601 currently recruiting?
Yes, NCT06126601 is actively recruiting participants. Contact the research team at studienzentrum-vtg@ukdd.de for enrollment information.
Where is the NCT06126601 trial being conducted?
This trial is being conducted at Dresden, Germany.
Who is sponsoring the NCT06126601 clinical trial?
NCT06126601 is sponsored by Technische Universität Dresden. The principal investigator is Marius Distler, Prof. Dr. at University Hospital Dresden. The trial plans to enroll 150 participants.