Evidence map›Paper›PMID 37660052›Full record

ArticleTrials2023

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

Haoda Chen, Ying Wang, Chao Wang, Xiaojian Lu, Yilong Li, Bei Sun, Kuirong Jiang, Yudong Qiu, Rufu Chen, Liping Cao and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05567094 (The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05567094 phase4completednot on this map

The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

TypeinterventionalSponsorRuijin HospitalRan2022 to 2023Enrolled300ConditionsPancreaticoduodenectomyArmsDexamethasone, Saline placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

Haoda Chen *Department of General Surgery, Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China.ORCID http://orcid.org/0000-0002-5774-0742
Ying Wang *Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China.
Chao Wang *Department of General Surgery, Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China.
Xiaojian Lu *Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China.
Yilong LiDepartment of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, China.
Bei SunDepartment of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, China.
Kuirong JiangPancreas Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yudong QiuDepartment of Biliary and Pancreatic Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Rufu ChenDepartment of Pancreatic Surgery, Department of General Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Liping CaoDepartment of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Shi ChenShengli Clinical Medical College of Fujian Medical University, Fuzhou, China.
Yan LuoDepartment of Anesthesiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China. ly11087@rjh.com.cn.
Baiyong ShenDepartment of General Surgery, Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China. shenby@shsmu.edu.cn.
Shanghai Jiao Tong University · CNHarbin Medical University · CNFujian Medical University · CNGuangdong Academy of Medical Sciences · CNJiangsu Province Hospital · CNNanjing Drum Tower Hospital · CNSir Run Run Shaw Hospital · CN

Funding

Ruijin Youth National Science Foundation Cultivation Fund KY2022668
6 · The paper itself

Abstract

backgroundPancreaticoduodenectomy (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.

methodsThe 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 registrationClinicalTrials.gov NCT05567094. Registered on 30 September 30 2022.

Indexed as

PancreatectomyPancreatitisAcute DiseaseDexamethasoneHumansIntestinesMulticenter Studies as TopicPancreaticoduodenectomyPostoperative ComplicationsPragmatic Clinical Trials as TopicProspective StudiesRandomized Controlled Trials as TopicDexamethasoneDexamethasonePancreaticoduodenectomyPostoperative complications

Identifiers

PMID37660052
PMCPMC10474642
OpenAlexW4386390855

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.