Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler
Recruiting · NCT06764134 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital Heidelberg
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- University Hospital Heidelberg - Heidelberg, Baden-Wurttemberg, Germany