Procalcitonin Reveals Early Dehiscence in Gastric Surgery: the PREDIGS Study

Gastric Cancer Clinical Trial

Official title:

Procalcitonin Reveals Early Dehiscence In Gastric Surgery: the PREDIGS Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02756455
• Other study ID #: PREDIGS
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2016
• Last updated: April 28, 2016
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: University of Roma La Sapienza
• Contact: Valentina Giaccaglia, MD
• Phone: +393397882429
• Email: v.giaccaglia[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• gastric cancer pts undergoing surgery
Measure PCT (procalcitonin), CRP (C-reactive protein) and WBC (white blood cell count) in 3rd and 5th postoperative day and registration of all intra and postoperative complications

Locations

Country	Name	City	State
Italy	Sant'Andrea University Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patients with leaks after gastric surgery correctly identified by the biomarkers (PCT and CRP)	PCT: procalcitonin, CRP: C-reactive protein	2 years	No
Primary	% of patients without leaks after gastric surgery correctly identified by PCT and CRP	PCT: procalcitonin, CRP: C-reactive protein	2 years	No
Secondary	PCT cut-off that gives good negative predictive (NPV) value for leak after gastric surgery in 3rd POD	procalcitonin (PCT) cuts-off in 3rd post-operative day (POD) with a good NPV	2 years	No
Secondary	PCT cut-off that gives good negative predictive value for leak after gastric surgery in 5th POD	PCT cuts-off in 5th POD with a good NPV	2 years	No