Evaluating pancreatic fistula rates after surgery using a specific stapler
Official title: Study Protocol for an Investigator Initiated, Observational Prospective Study, Evaluating the Rate of Postoperative Pancreatic Fistula in Distal Pancreatectomy Using AEON™ Endostapler
Run by University Hospital Heidelberg · NCT06764134 · Data updated 2026-11-12
This study is testing if using a specific stapler during pancreas surgery can lower the chances of complications like pancreatic fistulas in patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | University Hospital Heidelberg Academic / other |
| Locations | 1 site (Heidelberg, Baden-Wurttemberg) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | October 31, 2025 |
| Study ends | October 31, 2025 |
| Registry record updated | January 8, 2025 |
| Trial ID | NCT06764134 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older scheduled for distal pancreatectomy, with or without additional procedures.
✕Probably not a fit
Patients with a history of previous pancreatic surgeries or those requiring extensive multivisceral resections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the incidence of postoperative pancreatic fistula (POPF) in patients undergoing distal pancreatectomy (DP) with the AEON™ Endostapler. Involving 110 patients, the study will evaluate primary outcomes based on the International Study Group of Pancreatic Fistula (ISGPF) classification, alongside secondary perioperative parameters such as blood loss and hospital stay. Patients will be monitored postoperatively at various intervals to collect data on complications and recovery, with the goal of optimizing surgical techniques and improving patient outcomes.
Why it matters
Potential benefit: If successful, this study could lead to reduced rates of postoperative complications for patients undergoing distal pancreatectomy.
How similar studies have gone: While similar studies have explored postoperative complications in pancreatic surgery, the specific use of the AEON™ Endostapler in this context is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
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University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.