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Clinical Trials/NCT03780439
NCT03780439
Completed
Not Applicable

Diagnostic Accuracy of Procalcitonin as an Early Predictor of Infection After Radical Gastrectomy for Gastric Cancer: a Prospective Bi-center Study

Yongchang Zhang1 site in 1 country552 target enrollmentJune 1, 2018
ConditionsGastric Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
Yongchang Zhang
Enrollment
552
Locations
1
Primary Endpoint
diagnostic accuracy of procalcitonin to detect post-operative infection
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

Detailed Description

From June 2018 to May 2019, consecutive eligible patients who underwent surgery for gastric cancer in the Department of Gastroduodenal and Pancreatic Surgery, Hunan Cancer Hospital and the treatment group of Professor Kai-xiong Tao in the Union Hospital of Tongji Medical College were invited to participate in the study. After surgery, routine blood test were measured morning on post-operative day (POD) 1, 3, 5, and 7, and serum level of procalcitonin was measured morning on POD 3 and 5. The primary outcome of the present study was the accuracy of white blood cell (WBC) and neutrophil count, the neutrophil to WBC ratio (N%) and procalcitonin to detect post-operative infection (including intra-abdominal infection (IAI), surgical site infections (SSIs), pneumonia, urinary tract infection, catheter-related infection, and sepsis not specified) within 30 days after surgery. The main secondary outcome was their ability to detect any post-operative complications (such as intestinal obstruction, bleeding, ascites, cardiovascular and cerebrovascular events) within 30 days after surgery. Other secondary outcomes were the choice of the best timing to measure each inflammatory marker, the choice of a clinically meaningful cut-off value for the most accurate marker.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
July 28, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Yongchang Zhang
Responsible Party
Sponsor Investigator
Principal Investigator

Yongchang Zhang

Hunan Province Tumor Hospital

Hunan Province Tumor Hospital

Eligibility Criteria

Inclusion Criteria

  • pathologically diagnosed gastric adenocarcinoma
  • radical gastrectomy with lymphadenectomy.

Exclusion Criteria

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

Outcomes

Primary Outcomes

diagnostic accuracy of procalcitonin to detect post-operative infection

Time Frame: within 30 days after surgery

the accuracy of procalcitonin to detect post-operative infection

Secondary Outcomes

  • diagnostic accuracy of procalcitonin to detect overall post-operative complications(within 30 days after surgery)

Study Sites (1)

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