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Trials
Published in: Trials 1/2023

Open Access 01-12-2023 | Pancreatectomy | Study protocol

The effect of perioperative of dexamethasone on postoperative complications after pancreaticoduodenectomy (PANDEX): a study protocol for a pragmatic multicenter randomized controlled trial

Authors: Haoda Chen, Ying Wang, Chao Wang, Xiaojian Lu, Yilong Li, Bei Sun, Kuirong Jiang, Yudong Qiu, Rufu Chen, Liping Cao, Shi Chen, Yan Luo, Baiyong Shen

Published in: Trials | Issue 1/2023

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Abstract

Background

Pancreaticoduodenectomy (PD) nowadays serves as a standard treatment for patients with disorders of the pancreas, intestine, and bile duct. Although the mortality rate of patients undergoing PD has decreased significantly, postoperative complication rates remain high. Dexamethasone, a synthetic glucocorticoid with potent anti-inflammatory and metabolic effects, has been proven to have a favorable effect on certain complications. However, the role it plays in post-pancreatectomy patients has not been systematically evaluated. The aim of this study is to assess the effect of dexamethasone on postoperative complications after PD.

Methods

The PANDEX trial is an investigator-initiated, multicentric, prospective, randomized, double-blinded, placebo-control, pragmatic study. The trial is designed to enroll 300 patients who are going to receive elective PD. Patients will be randomized to receive 0.2 mg/kg dexamethasone or saline placebo, administered as an intravenous bolus within 5 min after induction of anesthesia. The primary outcome is the Comprehensive Complication Index (CCI) score within 30 days after the operation. The secondary outcomes include postoperative major complications (Clavien-Dindo≥3), postoperative pancreatic fistula (POPF), post-pancreatectomy acute pancreatitis (PPAP), infection, and unexpected relaparotomy, as well as postoperative length of stay, 30-day mortality, and 90-day mortality.

Discussion

The PANDEX trial is the first randomized controlled trial concerning the effect of dexamethasone on postoperative complications of patients undergoing PD, with the hypothesis that the intraoperative use of dexamethasone can reduce the incidence of postoperative complications and improve short-term outcomes after PD. The results of the present study will guide the perioperative use of dexamethasone and help improve the clinical management of post-pancreatectomy patients.

Trial registration

ClinicalTrials.gov NCT05567094. Registered on 30 September 30 2022
Appendix
Available only for authorised users
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Metadata
Title
The effect of perioperative of dexamethasone on postoperative complications after pancreaticoduodenectomy (PANDEX): a study protocol for a pragmatic multicenter randomized controlled trial
Authors
Haoda Chen
Ying Wang
Chao Wang
Xiaojian Lu
Yilong Li
Bei Sun
Kuirong Jiang
Yudong Qiu
Rufu Chen
Liping Cao
Shi Chen
Yan Luo
Baiyong Shen
Publication date
01-12-2023
Publisher
BioMed Central
Keyword
Pancreatectomy
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07571-y

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