Procalcitonin to Predict Infection After Gastrectomy for Gastric Cancer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03780439

Enrollment

552

Registered

2018-12-19

Start date

2018-06-01

Completion date

2019-07-28

Last updated

2019-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

procalcitonin, infection, gastric cancer, gastrectomy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
diagnostic accuracy of procalcitonin to detect post-operative infection	within 30 days after surgery	the accuracy of procalcitonin to detect post-operative infection

Secondary

Measure	Time frame	Description
diagnostic accuracy of procalcitonin to detect overall post-operative complications	within 30 days after surgery	the accuracy of procalcitonin to detect any post-operative complications

Countries

China

Outcome results