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Procalcitonin Reveals Early Dehiscence in Gastric Surgery: the PREDIGS Study

U

University of Roma La Sapienza

Status

Unknown

Conditions

Gastric Cancer

Treatments

Other: gastric cancer pts undergoing surgery

Study type

Observational

Funder types

Other

Identifiers

NCT02756455
PREDIGS

Details and patient eligibility

About

Background. Gastric cancer surgery is associated with high risk for postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood cell count (WBC).

Purpose. Investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after gastric surgery

Enrollment

100 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients undergoing all different kinds of gastric surgery (from partial to total gastrectomy) for cancer, WITH an anastomosis performed
  • elective setting

Exclusion criteria

  • age < 18 years
  • pregnant women
  • patients undergoing gastric surgery for benign disease or other kinds of gastric surgery without an anastomosis being performed

Trial design

100 participants in 1 patient group

gastric cancer pts undergoing surgery
Description:
all pts receiving gastric resection for cancer, with anastomosis
Treatment:
Other: gastric cancer pts undergoing surgery

Trial contacts and locations

1

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Central trial contact

Valentina Giaccaglia, MD

Data sourced from clinicaltrials.gov

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