The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy
Overview
- Phase
- Phase 4
- Intervention
- Dexamethasone
- Conditions
- Pancreaticoduodenectomy
- Sponsor
- Ruijin Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- The Comprehensive Complication Index (CCI)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of this clinical trial is evaluate the effect of dexamethasone on postoperative complications after pancreaticoduodenectomy.
Detailed Description
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 .
Investigators
BAIYONG SHEN
Professor
Ruijin Hospital
Eligibility Criteria
Inclusion Criteria
- •Adult patients ≥18 years of age;
- •An indication for elective PD surgery;
- •Patients understand the nature of this trial and are willing to comply;
- •Patients are able to provide written informed consent;
Exclusion Criteria
- •Current or recent (within preceding 1 month) systemic use of glucocorticoids;
- •Distant metastases including peritoneal carcinomatosis, liver metastases, distant lymph node metastases, and involvement of other organs;
- •Patients may undergo left, central, or total pancreatectomy other than PD;
- •Palliative surgery；
- •Patients with high operative risk, as defined by the American Society of Anesthesiologists (ASA), with a score ≥ 4;
- •Synchronous malignancy in other organs or second cancer requiring resection during the same procedure;
- •Pregnant and lactating women.
Arms & Interventions
Dexamethasone
Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Intervention: Dexamethasone
Saline placebo
Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Intervention: Saline placebo
Outcomes
Primary Outcomes
The Comprehensive Complication Index (CCI)
Time Frame: Within 30 days after the operation
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.
Secondary Outcomes
- The incidence of major complications (Clavien-Dindo≥3)(30 days)
- The incidence of postoperative pancreatic fistula (ISGPS classification)(30 days)
- The incidence of postpancreatectomy acute pancreatitis (ISGPS classification)(30 days)
- The incidence of infection (including wound infection and intra-abdominal abscess)(30 days)
- Postoperative length of stay(1 day of discharge)
- The incidence of relaparotomy(30 days)
- Mortality(60 days)