Klinische Studie

(Perioperative hydrocortisone treatment in pancreatoduodenectomy – randomised double-blinded placebo-controlled interventional trial)Primary: To compare the frequency of clinically relevant postoperative pancreatic fistula (POPF) after pancreatoduodenectomy between both treatment arms
Krankheitsentität(en) Bauchspeicheldrüse (Pankreas)
StudientypInterventionsstudiePhase II/III
Wesentliche EinschlusskriterienPatients with planned elective pancreatoduodenectomy [pancreatic head resection]; regardless of indication 2. Male or female patients aged ≥ 18 years without upper age limit 3. Written informed consent obtained according to international guidelines and local laws
Wesentliche Ausschlusskriterien1. Other perioperatively planned or pre-existing medication with a glucocorticoid in a dose of more than 30 mg hydrocortisone-equivalent per day (e.g. for PONV prophylaxis, autoimmune diseases) 2. Vaccination with live vaccine or live attenuated vaccine within the 4 weeks prior to surgery 3. Known hypersensitivity to the active substances or any of the excipients 4. Participation in any other interventional clinical trial within the last 30 days prior to hospitalization 5. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registries and diagnostic trials is allowed
Statusin Vorbereitung
Ansprechpartner & KontaktUniversitätsklinikum RegensburgChirurgieStudienzentrale0941 9446736cotrialassociates(at)ukr.de
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