Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler
Study Protocol for an Investigator Initiated, Observational Prospective Study, Evaluating the Rate of Postoperative Pancreatic Fistula in Distal Pancreatectomy Using AEON™ Endostapler
University Hospital Heidelberg
110 participants
Nov 1, 2024
OBSERVATIONAL
Conditions
Summary
This prospective, observational study evaluates the rate of postoperative pancreatic fistula (POPF) following distal pancreatectomy (DP) using the AEON™ Endostapler. The study involves 110 patients undergoing DP and assesses primary outcomes based on the International Study Group of Pancreatic Fistula (ISGPF) classification, alongside secondary perioperative parameters. The findings aim to optimize surgical techniques, reduce complications, and improve healthcare outcomes.
Eligibility
Inclusion Criteria4
- Age 18 years or older.
- Ability to understand the nature and consequences of the study.
- Provision of written informed consent.
- Scheduled for minimally invasive or open distal pancreatectomy (DP) for any indication, with or without splenectomy and/or left adrenalectomy.
Exclusion Criteria5
- Inability to comply with study procedures or follow-up.
- Multivisceral resection beyond left adrenalectomy.
- History of previous pancreatic surgeries.
- Expected lack of compliance with the study protocol.
- Participation in another trial that may interfere with the intervention or outcomes of this study.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06764134