Evaluating pancreatic fistula rates after surgery using a specific stapler
Study Protocol for an Investigator Initiated, Observational Prospective Study, Evaluating the Rate of Postoperative Pancreatic Fistula in Distal Pancreatectomy Using AEON™ Endostapler
University Hospital Heidelberg · NCT06764134
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 |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg (other) |
| Locations | 1 site (Heidelberg, Baden-Wurttemberg) |
| Trial ID | NCT06764134 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for distal pancreatectomy, with or without additional procedures.
Not a fit: Patients with a history of previous pancreatic surgeries or those requiring extensive multivisceral resections may not benefit from this study.
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 performed: While similar studies have explored postoperative complications in pancreatic surgery, the specific use of the AEON™ Endostapler in this context is novel.
Eligibility criteria
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 this trial is running
Heidelberg, Baden-Wurttemberg
- University Hospital Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreas, Fistula, Pancreas Cancer, Pancreatic Disease, Surgery-Complications, Surgery