Clinical trial NCT03780439: Procalcitonin to Predict Infection After Gastrectomy for Gastric Cancer
Official title: Diagnostic Accuracy of Procalcitonin as an Early Predictor of Infection After Radical Gastrectomy for Gastric Cancer: a Prospective Bi-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: procalcitonin
infection
gastric cancer
gastrectomy
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
Collaborators: name: Huazhong University of Science and Technology
First posted: 2018-12-19
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pathologically diagnosed gastric adenocarcinoma who underwent radical 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.

Eligibility criteria: 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

Primary outcomes:
measure: diagnostic accuracy of procalcitonin to detect post-operative infection
timeFrame: within 30 days after surgery
Secondary outcomes:
measure: diagnostic accuracy of procalcitonin to detect overall post-operative complications
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Province Tumor Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Hua Xiao
role: PRINCIPAL_INVESTIGATOR
References:
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 IMACORS Study. Ann Surg. 2016 May;263(5):961-6. doi: 10.1097/SLA.0000000000001303.
citation: 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. 2016 Aug;264(2):252-6. doi: 10.1097/SLA.0000000000001545.
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 transfusion and role of leukocyte depletion. J Cancer Res Clin Oncol. 2018 Jun;144(6):1143-1154. doi: 10.1007/s00432-018-2630-8. Epub 2018 Mar 23.
citation: Munoz JL, Ruiz-Tovar J, Miranda E, Berrio DL, Moya P, Gutierrez M, Flores R, Pico C, Perez A. C-Reactive Protein and Procalcitonin as Early Markers of Septic Complications after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients Within an Enhanced Recovery After Surgery Program. J Am Coll Surg. 2016 May;222(5):831-7. doi: 10.1016/j.jamcollsurg.2016.01.059. Epub 2016 Feb 13.