Procalcitonin to Predict Infection After Gastrectomy for Gastric Cancer

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT03780439
• Lead Sponsor: Yongchang Zhang

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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-15
• Study First Posted: 2018-12-19
• Primary Completion: 2019-07-28
• Study Completion: 2019-07-28
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-22
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 552

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy of procalcitonin to detect post-operative infection	within 30 days after surgery	the accuracy of procalcitonin to detect post-operative infection

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hunan Province Tumor Hospital; 🇨🇳 Changsha, Hunan, China