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Completed

NCT Number: NCT03780439

Procalcitonin to Predict Infection After Gastrectomy for Gastric Cancer

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Infections Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hunan Province Tumor Hospital

Changsha, Hunan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. diagnostic accuracy of procalcitonin to detect post-operative infection

    Time frame: within 30 days after surgery

    the accuracy of procalcitonin to detect post-operative infection

Secondary outcomes

  1. diagnostic accuracy of procalcitonin to detect overall post-operative complications

    Time frame: within 30 days after surgery

    the accuracy of procalcitonin to detect any post-operative complications

Sponsors and collaborators

Lead sponsor

Yongchang Zhang

Other

Collaborators

  • Huazhong University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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