Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population consists of adult patients aged 18 years or older scheduled to undergo minimally invasive or open distal pancreatectomy (DP) for any indication, with or without splenectomy and/or left adrenalectomy. These patients will be recruited from the University of Heidelberg and screened for eligibility based on inclusion and exclusion criteria. Participants must provide informed consent and demonstrate the ability to comply with study procedures and follow-up assessments.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 90 days post-surgery.Sponsors and contacts
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Source ClinicalTrials.gov