Procalcitonin to Predict Infection After Gastrectomy for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780439
• Other study ID #: PCT-INFECTION
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: July 28, 2019

Study information

• Verified date: September 2019
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: July 28, 2019
• Est. primary completion date: July 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Infection
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Hunan Province Tumor Hospital	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Yongchang Zhang	Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (4)

Cousin F, Ortega-Deballon P, Bourredjem A, Doussot A, Giaccaglia V, Fournel I. Diagnostic Accuracy of Procalcitonin and C-reactive Protein for the Early Diagnosis of Intra-abdominal Infection After Elective Colorectal Surgery: A Meta-analysis. Ann Surg. 2 — View Citation

Facy O, Paquette B, Orry D, Binquet C, Masson D, Bouvier A, Fournel I, Charles PE, Rat P, Ortega-Deballon P; IMACORS Study. Diagnostic Accuracy of Inflammatory Markers As Early Predictors of Infection After Elective Colorectal Surgery: Results From the IM — View Citation

Muñoz JL, Ruiz-Tovar J, Miranda E, Berrio DL, Moya P, Gutiérrez M, Flores R, Picó C, Pérez A. C-Reactive Protein and Procalcitonin as Early Markers of Septic Complications after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients Within an Enhanced — View Citation

Xiao H, Quan H, Pan S, Yin B, Luo W, Huang G, Ouyang Y. Impact of peri-operative blood transfusion on post-operative infections after radical gastrectomy for gastric cancer: a propensity score matching analysis focusing on the timing, amount of transfusio — View Citation

Outcome

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