Procalcitonin Reveals Early Dehiscence in Gastric Surgery: the PREDIGS Study

NCT02756455 | Unknown DMC

• 1 other identifier: PREDIGS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer

Keywords

gastric cancer; procalcitonin

Outcome Measures

Primary Outcomes (2)

• % of patients with leaks after gastric surgery correctly identified by the biomarkers (PCT and CRP)

  PCT: procalcitonin, CRP: C-reactive protein

  2 years

• % of patients without leaks after gastric surgery correctly identified by PCT and CRP

  PCT: procalcitonin, CRP: C-reactive protein

  2 years

Secondary Outcomes (2)

• PCT cut-off that gives good negative predictive (NPV) value for leak after gastric surgery in 3rd POD

  2 years

• PCT cut-off that gives good negative predictive value for leak after gastric surgery in 5th POD

  2 years

Study Arms (1)

gastric cancer pts undergoing surgery

all pts receiving gastric resection for cancer, with anastomosis

Other: gastric cancer pts undergoing surgery

Interventions

gastric cancer pts undergoing surgery OTHER

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

gastric cancer pts undergoing surgery

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing gastric cancer surgery in our institution

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sant'Andrea University Hospital

Rome, 00189, Italy

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Valentina Giaccaglia, MD

CONTACT

+393397882429; v.giaccaglia@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 29, 2016
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 29, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)