Pancreaticoduodenectomy
Conditions
Keywords
Pancreaticoduodenectomy, Dexamethasone, Postoperative complications, Double-blind, Pragmatic, Superiority trial
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 .
Interventions
DRUGDexamethasone
Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia
DRUGSaline placebo
Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patients, surgeons, anesthetists, data collectors, and outcome assessors are all blinded. Only the data manager and the specific study coordinator are unblinded to the group allocation.
Intervention model description
Patients 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients ≥18 years of age; 2. An indication for elective PD surgery; 3. Patients understand the nature of this trial and are willing to comply; 4. Patients are able to provide written informed consent;
Exclusion criteria
1. Current or recent (within preceding 1 month) systemic use of glucocorticoids; 2. Distant metastases including peritoneal carcinomatosis, liver metastases, distant lymph node metastases, and involvement of other organs; 3. Patients may undergo left, central, or total pancreatectomy other than PD; 4. Palliative surgery； 5. Patients with high operative risk, as defined by the American Society of Anesthesiologists (ASA), with a score ≥ 4; 6. Synchronous malignancy in other organs or second cancer requiring resection during the same procedure; 7. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Comprehensive Complication Index (CCI) | 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
| Measure | Time frame |
|---|---|
| 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 |
| The incidence of major complications (Clavien-Dindo≥3) | 30 days |
| The incidence of relaparotomy | 30 days |
| Mortality | 30 days |
| Postoperative length of stay | 1 day of discharge |
Countries
China
Outcome results
None listed