Perioperative hydrocortisone treatment in pancreatoduodenectomy – randomised double-blinded placebo-controlled interventional trial (PD-HYDRA)

Conditions

Pancreatic resection

Brief summary

1. Post-operative pancreatic fistula of grade B or worse within 90 days after surgery (POPF B/C)

Detailed description

2. POPF B/C within 90 days after pancreatoduodenectomy, 3. Overall survival within one year (OS), 4. Grade IIIb or worse complication in the Clavien-Dindo Classification (CDC) within 90 days after surgery (CDC IIIb+), 6. Grade C postpancreatectomy haemorrhage within 90 days after surgery (PPH C), 7. Grade B or worse delayed gastric emptying within 90 days after surgery (DGE B/C), 8. Grade B or worse bile leak within 90 days after surgery (BL B/C), 9. Grade B or worse chyle leak within 90 days after surgery (CL B/C), 10. Completion pancreatectomy within 90 days after surgery, 11. Surgical site infection within 90 days after surgery, 12. Pneumonia within 90 days after first dose, 13. Cholangitis within 90 days after first dose, (Serious) adverse events ((S)AE), 5. Grade B or worse postpancreatectomy acute pancreatitis within 90 days after surgery (PPAP B/C)

Related papers

No related papers found yet.

Interventions

DRUGSODIUM CHLORIDE

DRUGHYDROCORTISON Pfizer 100 mg sine Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
2. POPF B/C within 90 days after pancreatoduodenectomy, 3. Overall survival within one year (OS), 4. Grade IIIb or worse complication in the Clavien-Dindo Classification (CDC) within 90 days after surgery (CDC IIIb+), 6. Grade C postpancreatectomy haemorrhage within 90 days after surgery (PPH C), 7. Grade B or worse delayed gastric emptying within 90 days after surgery (DGE B/C), 8. Grade B or worse bile leak within 90 days after surgery (BL B/C), 9. Grade B or worse chyle leak within 90 days after surgery (CL B/C), 10. Completion pancreatectomy within 90 days after surgery, 11. Surgical site infection within 90 days after surgery, 12. Pneumonia within 90 days after first dose, 13. Cholangitis within 90 days after first dose, (Serious) adverse events ((S)AE), 5. Grade B or worse postpancreatectomy acute pancreatitis within 90 days after surgery (PPAP B/C)	—

Measure

Time frame

2. POPF B/C within 90 days after pancreatoduodenectomy, 3. Overall survival within one year (OS), 4. Grade IIIb or worse complication in the Clavien-Dindo Classification (CDC) within 90 days after surgery (CDC IIIb+), 6. Grade C postpancreatectomy haemorrhage within 90 days after surgery (PPH C), 7. Grade B or worse delayed gastric emptying within 90 days after surgery (DGE B/C), 8. Grade B or worse bile leak within 90 days after surgery (BL B/C), 9. Grade B or worse chyle leak within 90 days after surgery (CL B/C), 10. Completion pancreatectomy within 90 days after surgery, 11. Surgical site infection within 90 days after surgery, 12. Pneumonia within 90 days after first dose, 13. Cholangitis within 90 days after first dose, (Serious) adverse events ((S)AE), 5. Grade B or worse postpancreatectomy acute pancreatitis within 90 days after surgery (PPAP B/C)

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Primary

Measure	Time frame
1. Post-operative pancreatic fistula of grade B or worse within 90 days after surgery (POPF B/C)	—

Countries

Germany

Outcome results

None listed