RecruitingNCT06764134

Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler

Study Protocol for an Investigator Initiated, Observational Prospective Study, Evaluating the Rate of Postoperative Pancreatic Fistula in Distal Pancreatectomy Using AEON™ Endostapler


Sponsor

University Hospital Heidelberg

Enrollment

110 participants

Start Date

Nov 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether using a specific stapling device (the AEON Endostapler) during distal pancreatectomy (surgical removal of part of the pancreas) reduces the rate of a common complication called pancreatic fistula — a leak of pancreatic fluid after surgery. **You may be eligible if...** - You are 18 or older - You are scheduled for minimally invasive or open distal pancreatectomy for any reason - Your surgery may include removal of the spleen and/or left adrenal gland - You are able to understand and sign an informed consent form **You may NOT be eligible if...** - You have had previous pancreatic surgery - Your planned surgery involves removal of multiple other organs beyond the left adrenal gland - You are unable to comply with study procedures or follow-up - You are participating in another trial that may interfere with results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

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NCT06764134


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