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Study Protocol for an Investigator Initiated, Observational Prospective Study Evaluating Postoperative Pancreatic Fistula Rate After Distal Pancreatectomy Using AEON1732 Endostapler
Led by University Hospital Heidelberg · Updated on 2025-01-08
110
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are conducting a prospective, observational study to evaluate the rate of postoperative pancreatic fistula (POPF) in patients undergoing distal pancreatectomy (DP) using the AEON1732 Endostapler. POPF is a serious complication after DP, and this study aims to better understand its incidence to improve surgical techniques and healthcare outcomes. The study involves 110 patients who are scheduled for DP for various reasons and who provide informed consent. The study focuses on patients undergoing minimally invasive or open DP, with or without splenectomy or left adrenalectomy. There is no intervention assigned since this is an observational study assessing the use of the AEON1732 Endostapler during surgery. Follow-up evaluations occur at postoperative days 1, 3, 14, 30, and 90 to monitor outcomes and complications. Participants will have their pancreatic leakage monitored by measuring amylase levels in drain fluid at set intervals after surgery. Researchers will collect data on the primary outcome, which is the rate of clinically relevant POPF according to International Study Group of Pancreatic Fistula criteria, along with secondary perioperative parameters like blood loss, operation time, ICU and hospital stays, reoperation rates, and 90-day mortality. The total study period extends up to 90 days post-surgery for each participant.
CONDITIONS
Brief Title
Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 for any indication, with or without splenectomy and/or left adrenalectomy
You will not qualify if you...
- 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 this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay duration post-surgery
Participants undergo distal pancreatectomy surgery using the AEON™ Endostapler and receive immediate post-operative care to monitor for complications including pancreatic fistula.
Visits on postoperative days 1, 3, and 14
Duration - Up to 90 days post-surgery
Participants are followed up to monitor recovery and assess postoperative pancreatic fistula and other outcomes up to 90 days after surgery.
Visits on postoperative days 30 and 90
Trial Site Locations
Total: 1 location
1
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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