Procalcitonin Reveals Early Dehiscence in Gastric Surgery: the PREDIGS Study

• Conditions: Gastric Cancer
• Interventions: Other: gastric cancer pts undergoing surgery

• Registration Number: NCT02756455
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Status Verified: 2016-04
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-28
• Last Update Submitted: 2016-04-28
• Study First Posted: 2016-04-29
• Last Update Posted: 2016-04-29
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
gastric cancer pts undergoing surgery	gastric cancer pts undergoing surgery	all pts receiving gastric resection for cancer, with anastomosis

Primary Outcome Measures

Name	Time	Method
% of patients without leaks after gastric surgery correctly identified by PCT and CRP	2 years	PCT: procalcitonin, CRP: C-reactive protein
% of patients with leaks after gastric surgery correctly identified by the biomarkers (PCT and CRP)	2 years	PCT: procalcitonin, CRP: C-reactive protein

Secondary Outcome Measures

Name	Time	Method
PCT cut-off that gives good negative predictive (NPV) value for leak after gastric surgery in 3rd POD	2 years	procalcitonin (PCT) cuts-off in 3rd post-operative day (POD) with a good NPV
PCT cut-off that gives good negative predictive value for leak after gastric surgery in 5th POD	2 years	PCT cuts-off in 5th POD with a good NPV

Trial Locations

Locations (1)

Sant'Andrea University Hospital; 🇮🇹 Rome, Italy