The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

Phase 4

Completed

• Conditions: Pancreaticoduodenectomy
• Interventions: Drug: Saline placebo; Drug: Dexamethasone

• Registration Number: NCT05567094
• Lead Sponsor: Ruijin Hospital

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 .

Study Timeline

• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-10-01
• Study First Posted: 2022-10-05
• Study Start: 2022-10-08
• Status Verified: 2023-09
• Primary Completion: 2023-09-14
• Study Completion: 2023-09-14
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline placebo	Saline placebo	Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia
Dexamethasone	Dexamethasone	Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China