Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-01-07 @ 3:47 AM
Study NCT ID:
NCT06764134
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler
Sponsor:
University Hospital Heidelberg
Organization:
Study Overview
Official Title:
Study Protocol for an Investigator Initiated, Observational Prospective Study, Evaluating the Rate of Postoperative Pancreatic Fistula in Distal Pancreatectomy Using AEON™ Endostapler
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AEON-DP
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: