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Procalcitonin to Predict Infection After Gastrectomy for Gastric Cancer

Y

Yongchang Zhang

Status

Completed

Conditions

Gastric Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT03780439
PCT-INFECTION

Details and patient eligibility

About

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

Full 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.

Enrollment

552 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. ≥ 18 years
  2. pathologically diagnosed gastric adenocarcinoma
  3. radical gastrectomy with lymphadenectomy.

Exclusion criteria

  1. ongoing infection at surgery
  2. pregnancy status
  3. underwent non-resection surgery
  4. underwent palliative gastrectomy
  5. emergency surgery
  6. taking corticosteroid or other immunosuppressive drugs

Trial design

552 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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