RecruitingNot Applicable

Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler

Germany110 participantsStarted 2024-11-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Rate of Clinically Relevant Postoperative Pancreatic Fistula (POPF)

Timeframe: Up to 90 days post-surgery.

Trial details

NCT IDNCT06764134

SponsorUniversity Hospital Heidelberg

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Pancreas; Fistula trials