NCT06764134Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 110 (estimated)
- First submitted
- 2 Jan 2025
- Start date
- 1 Nov 2024
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- University Hospital Heidelberg
- Diseases
- Pancreatic cancer
- NCT number
- NCT06764134
What you commit to
- Study type: Observational
- Planned participants: 110
- From 1 Nov 2024 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Multivisceral resection beyond left adrenalectomy.
- History of previous pancreatic surgeries.
Other
- Inability to comply with study procedures or follow-up.
- Expected lack of compliance with the study protocol.
- Participation in another trial that may interfere with the intervention or outcomes of this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.