The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

Study Overview
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Brief Summary
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The primary objective of this clinical trial is evaluate the effect of dexamethasone on postoperative complications after pancreaticoduodenectomy.

Detailed Description
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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 .

Official Title
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The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

Conditions
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Pancreaticoduodenectomy

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Saline placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia | Drug: Dexamethasone<br>* Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia<br>|
| Placebo Comparator: Saline placebo<br>Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia | Drug: Saline placebo<br>* Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 30 days after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 30 days | 
| Mortality |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreaticoduodenectomy, Dexamethasone, Postoperative complications, Double-blind, Pragmatic, Superiority trial