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COMPLETEDPhase 4NCT05567094

The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

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

Lead sponsor: Ruijin Hospital•1 locations•View source on ClinicalTrials.gov

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What this study is about

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Sponsors

Lead Sponsor

Ruijin Hospital

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 .

Age

18 - No limit years

Sex

ALL

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 18, 2023Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment300

Start dateOct 2022

Last updatedSep 18, 2023

Condition

Pancreaticoduodenectomy

Locations shown

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2023Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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