Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler

Study Overview

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.

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.

Pancreas; Fistula
Pancreas Cancer
Pancreatic Disease
Surgery-Complications
Surgery

S-473/2024

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-01-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-01-02
First Submitted that Met QC Criteria 2025-01-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-01-08
First Posted (ACTUAL) 2025-01-08	Results First Posted N/A	Last Verified 2025-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Rate of Clinically Relevant Postoperative Pancreatic Fistula (POPF)	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.	Up to 90 days post-surgery.

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

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Publications

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