Procalcitonin to Predict Infection After Gastrectomy for Gastric Cancer

Study 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.

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

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| infection group and non-infection group<br>patients were divided into 2 sub-groups according to the presence of infection or not after radical gastrectomy for gastric cancer. | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
procalcitonin, gastrectomy, infection, gastric cancer