The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-08

Study Completion Date

2023-09-14

Brief Summary

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

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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 .

Conditions

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Pancreaticoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Dexamethasone

Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Saline placebo

Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Group Type PLACEBO_COMPARATOR

Saline placebo

Intervention Type DRUG

Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Interventions

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Dexamethasone

Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Intervention Type DRUG

Saline placebo

Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No