NCT06764134

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, observational, monocentric study designed to evaluate the incidence of postoperative pancreatic fistula (POPF) following distal pancreatectomy (DP) performed using the AEON™ Endostapler. POPF is one of the most serious complications after DP, and effective stump closure remains a critical challenge in reducing its occurrence. The study will involve 110 patients who meet the inclusion criteria and undergo DP at the University of Heidelberg. Primary outcomes will focus on the rate of clinically relevant POPF as defined by the International Study Group of Pancreatic Fistula (ISGPF). Secondary outcomes include intraoperative and postoperative parameters, such as estimated blood loss, operation duration, ICU and hospital stay, reoperation rates, and 90-day mortality. All outcomes will be assessed following standardized protocols. Patients will be enrolled after providing informed consent and will receive follow-up evaluations at specific time points, including postoperative days 1, 3, 14, 30, and 90. Amylase levels in drain fluid will be measured to monitor pancreatic leakage. Data collected during the study will be analyzed to assess the effectiveness and safety of the AEON™ Endostapler in reducing POPF and other complications. The findings aim to contribute critical evidence to improve surgical practices and outcomes for DP patients, potentially shaping future guidelines and reducing healthcare costs.

Conditions

• Pancreas; Fistula
• Pancreas Cancer
• Pancreatic Disease
• Surgery-Complications
• Surgery

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2025-01-08
• Last updated: 2025-01-08

Locations

1 site across 1 country: Germany