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NCT05680623
Clinical and Economic Validation of the ISGPS Definition of PPAP
Conditions: Postoperative Acute Pancreatitis, Pancreaticoduodenectomy, Postoperative Pancreatic Fistula, Postoperative Complications
Sex: All
Ages: 18 Years – N/A
Enrollment: 3000
Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Location: Italy
Summary
This prospective validation study aims to investigate the incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system, to demonstrate its clinical impact by examining associated postoperative outcomes, and to validate its applicability through an economic assessment.
Eligibility Criteria
Inclusion Criteria:Scheduled for elective PD;Male and females ≥ 18 years;Upfront or after neoadjuvant therapy surgery is allowed;The ability of the subject to understand the character and individual consequences of the clinical trial;Written informed consent.Exclusion Criteria:Patients undergoing emergency surgery;Informed consent withdrawal;Inability to perform the resection for any reason;Total or distal pancreatectomy.
Source: ClinicalTrials.gov (NCT05680623). StuddyBuddy aggregates publicly available trial information.