Observational Study to Evaluate Postoperative Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler Sponsored by University Hospital Heidelberg

What this Trial Is About

Researchers are evaluating the rate of postoperative pancreatic fistula (POPF), a serious complication, following distal pancreatectomy (DP) using the AEON173 Endostapler. This prospective, observational study involves 110 patients undergoing DP at the University of Heidelberg. The study aims to optimize surgical techniques and improve patient outcomes by assessing the occurrence of POPF and other perioperative factors. The study includes patients scheduled for minimally invasive or open distal pancreatectomy, with or without splenectomy or left adrenalectomy, using the AEON173 Endostapler for pancreas stump closure. There are no interventions beyond standard surgical care since this is an observational study. Patients are enrolled after informed consent and monitored for complications and outcomes over time. Participants will be followed up on postoperative days 1, 3, 14, 30, and 90 with evaluations including measurement of amylase levels in drain fluid to detect pancreatic leakage. Researchers will assess the rate of clinically relevant POPF according to established guidelines, as well as other outcomes like blood loss, operation time, ICU and hospital stay length, reoperation rates, and 90-day mortality. Data collected will help inform safer surgical practices and potentially reduce healthcare costs.

Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler