Obsidian® ASG Autologous Platelet-Rich Fibrin Matrix for the prevention of postoperative pancreatic fistula following pancreatic resection –A feasibility pilot trial
- Conditions
- complications after partial pancreatectomy
- Registration Number
- DRKS00034052
- Lead Sponsor
- Medizinische Universität Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 25
Scheduled for elektive partial pancreatic resection, due to any underlying disease.
Inclusion criteria comprise =18 years of age, ability to understand character and individual consequences of the clinical trial, as well as written informed consent. For patients with childbearing potential, presence of preoperative negative urine or negative blood pregnancy test and adequate contraception until 14 days after trial intervention is required. Patients with severe systemic disease that is a constant threat to life, classified as American Society of Anaesthesiologists’ (ASA) score >3 and patients with known hypersensitivity to any component in the formulation will be excluded as will be patients with understanding or language problems and patients with inability to comply with the study and/or follow-up procedures. Pregnant and breast-feeding patients as well as patients with concurrent participation in another interventional clinical trial with interference with the trial outcome will also be excluded.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the feasibility of the procedure, e.g. proportion of patients undergoing successful trial intervention.
- Secondary Outcome Measures
Name Time Method Secondary endpoints comprise safety and surgical outcome parameters including rate and severity of POPF as well as further pancreas-specific complications as defined by the International Study Group of Pancreatic Surgery (ISGPS) during 90 days after surgery.