NCT03780439

Brief Summary

To investigate the diagnostic accuracy of procalcitonin as an early predictor of infection after radical gastrectomy for gastric cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
552

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2019

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

1.2 years

First QC Date

December 13, 2018

Last Update Submit

September 22, 2019

Conditions

Gastric Cancer

Keywords

procalcitonininfectiongastric cancergastrectomy

Outcome Measures

Primary Outcomes (1)

  • diagnostic accuracy of procalcitonin to detect post-operative infection

    the accuracy of procalcitonin to detect post-operative infection

    within 30 days after surgery

Secondary Outcomes (1)

  • diagnostic accuracy of procalcitonin to detect overall post-operative complications

    within 30 days after surgery

Study Arms (1)

infection group and non-infection group

patients were divided into 2 sub-groups according to the presence of infection or not after radical gastrectomy for gastric cancer.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with pathologically diagnosed gastric adenocarcinoma who underwent radical gastrectomy.

You may qualify if:

  • ≥ 18 years
  • pathologically diagnosed gastric adenocarcinoma
  • radical gastrectomy with lymphadenectomy.

You may not qualify if:

  • ongoing infection at surgery
  • pregnancy status
  • underwent non-resection surgery
  • underwent palliative gastrectomy
  • emergency surgery
  • taking corticosteroid or other immunosuppressive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Province Tumor Hospital

Changsha, Hunan, China

Location

Related Publications (4)

  • Facy O, Paquette B, Orry D, Binquet C, Masson D, Bouvier A, Fournel I, Charles PE, Rat P, Ortega-Deballon P; IMACORS Study. Diagnostic Accuracy of Inflammatory Markers As Early Predictors of Infection After Elective Colorectal Surgery: Results From the IMACORS Study. Ann Surg. 2016 May;263(5):961-6. doi: 10.1097/SLA.0000000000001303.

    PMID: 26135691RESULT

  • Cousin F, Ortega-Deballon P, Bourredjem A, Doussot A, Giaccaglia V, Fournel I. Diagnostic Accuracy of Procalcitonin and C-reactive Protein for the Early Diagnosis of Intra-abdominal Infection After Elective Colorectal Surgery: A Meta-analysis. Ann Surg. 2016 Aug;264(2):252-6. doi: 10.1097/SLA.0000000000001545.

    PMID: 27049766RESULT

  • Xiao H, Quan H, Pan S, Yin B, Luo W, Huang G, Ouyang Y. Impact of peri-operative blood transfusion on post-operative infections after radical gastrectomy for gastric cancer: a propensity score matching analysis focusing on the timing, amount of transfusion and role of leukocyte depletion. J Cancer Res Clin Oncol. 2018 Jun;144(6):1143-1154. doi: 10.1007/s00432-018-2630-8. Epub 2018 Mar 23.

    PMID: 29572591RESULT

  • Munoz JL, Ruiz-Tovar J, Miranda E, Berrio DL, Moya P, Gutierrez M, Flores R, Pico C, Perez A. C-Reactive Protein and Procalcitonin as Early Markers of Septic Complications after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients Within an Enhanced Recovery After Surgery Program. J Am Coll Surg. 2016 May;222(5):831-7. doi: 10.1016/j.jamcollsurg.2016.01.059. Epub 2016 Feb 13.

    PMID: 27010585RESULT

MeSH Terms

Conditions

Stomach NeoplasmsInfections

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Hua Xiao

    Hunan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Hunan Province Tumor Hospital

Study Record Dates

First Submitted

December 13, 2018

First Posted

December 19, 2018

Study Start

June 1, 2018

Primary Completion

July 28, 2019

Study Completion

July 28, 2019

Last Updated

September 24, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)