Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler

Recruiting

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

• Registration Number: NCT06764134
• Lead Sponsor: University Hospital Heidelberg

Brief 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.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Clinically Relevant Postoperative Pancreatic Fistula (POPF)	Up to 90 days post-surgery.	The rate of clinically relevant POPF will be assessed based on the International Study Group of Pancreatic Fistula (ISGPF) definition, which includes drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content exceeding three times the upper limit of normal serum amylase activity, associated with a clinically relevant condition.

Trial Locations

Locations (1)

University Hospital Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany