complications after partial pancreatectomy
Conditions
Interventions
Group 1: Patients scheduled for elective formal partial pancreatectomy due to any underlying disease will be included according to the eligibility criteria. Obsidian® ASG sealant prepared out of 120mL
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Scheduled for elektive partial pancreatic resection, due to any underlying disease.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the feasibility of the procedure, e.g. proportion of patients undergoing successful trial intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Austria
Contacts
Public ContactUlla Klaiber
Medizinische Universität Wien
Outcome results
None listed