An observational study in Pancreas; Fistula, Pancreas Cancer and Pancreatic Disease, sponsored by University Hospital Heidelberg. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by University Hospital Heidelberg · Observational
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.
This is a prospective, observational, monocentric study designed to evaluate the incidence of postoperative pancreatic fistula (POPF) following distal pancreatectomy (DP) performed using the AEON™ Endostapler. POPF is one of the most serious complications after DP, and effective stump closure remains a critical challenge in reducing its occurrence. The study will involve 110 patients who meet the inclusion criteria and undergo DP at the University of Heidelberg.
Primary outcomes will focus on the rate of clinically relevant POPF as defined by the International Study Group of Pancreatic Fistula (ISGPF). Secondary outcomes include intraoperative and postoperative parameters, such as estimated blood loss, operation duration, ICU and hospital stay, reoperation rates, and 90-day mortality. All outcomes will be assessed following standardized protocols.
Patients will be enrolled after providing informed consent and will receive follow-up evaluations at specific time points, including postoperative days 1, 3, 14, 30, and 90. Amylase levels in drain fluid will be measured to monitor pancreatic leakage. Data collected during the study will be analyzed to assess the effectiveness and safety of the AEON™ Endostapler in reducing POPF and other complications.
The findings aim to contribute critical evidence to improve surgical practices and outcomes for DP patients, potentially shaping future guidelines and reducing healthcare costs.
122 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's planned enrollment of 110 is close to the median of 120 across 44 observational studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →University Hospital Heidelberg is the lead sponsor of 177 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of adult patients aged 18 years or older scheduled to undergo minimally invasive or open distal pancreatectomy (DP) for any indication, with or without splenectomy and/or left adrenalectomy. These patients will be recruited from the University of Heidelberg and screened for eligibility based on inclusion and exclusion criteria. Participants must provide informed consent and demonstrate the ability to comply with study procedures and follow-up assessments.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rate of Clinically Relevant Postoperative Pancreatic Fistula (POPF)
The rate of clinically relevant POPF will be assessed based on the International Study Group of Pancreatic Fistula (ISGPF) definition, which includes drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content exceeding three times the upper limit of normal serum amylase activity, associated with a clinically relevant condition.
Time frame: Up to 90 days post-surgery.
Started Nov 2024 (actual). Primary completion is estimated for Oct 2025, 11 months after the start.
Of 22 observational studies under Pancreatic Fistula, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 53. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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