NCT06764134 Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler
| NCT ID | NCT06764134 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Heidelberg |
| Condition | Pancreas; Fistula |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2024-11-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT06764134 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreas; Fistula. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06764134 currently recruiting?
Yes, NCT06764134 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital Heidelberg to inquire about joining.
Where is the NCT06764134 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT06764134 clinical trial?
NCT06764134 is sponsored by University Hospital Heidelberg. The trial plans to enroll 110 participants.