The primary objective of this clinical trial is evaluate the effect of dexamethasone on postoperative complications after pancreaticoduodenectomy.
This is a multicentric, prospective, randomized, double-blind, pragmatic, placebo-control study. Patients who are going to receive elective pancreaticoduodenectomy will be randomized to receive 0.2 mg/kg dexamethasone or saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia. The primary outcome is the Comprehensive Complication Index (CCI) score within 30 days after the operation, which will be compared between these two groups .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
300
Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
The Comprehensive Complication Index (CCI)
The Comprehensive Complication Index (CCI) score within 30 days after the operation. The CCI takes into account all cumulative complications and receives values between 0 and 100. The weight of complication (wC) of the CCI is based on the established Clavien-Dindo classification.
Time frame: Within 30 days after the operation
The incidence of major complications (Clavien-Dindo≥3)
Time frame: 30 days
The incidence of postoperative pancreatic fistula (ISGPS classification)
Time frame: 30 days
The incidence of postpancreatectomy acute pancreatitis (ISGPS classification)
Time frame: 30 days
The incidence of infection (including wound infection and intra-abdominal abscess)
Time frame: 30 days
Postoperative length of stay
Time frame: 1 day of discharge
The incidence of relaparotomy
Time frame: 30 days
Mortality
Time frame: 30 days
Mortality
Time frame: 60 days
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