Procalcitonin Reveals Early Dehiscence in Gastric Surgery: the PREDIGS Study

April 28, 2016 updated by: Valentina Giaccaglia, University of Roma La Sapienza

Procalcitonin Reveals Early Dehiscence In Gastric Surgery: the PREDIGS Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00189
        • Recruiting
        • Sant'Andrea University Hospital
        • Contact:
        • Principal Investigator:
          • Valentina Giaccaglia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing gastric cancer surgery in our institution

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
gastric cancer pts undergoing surgery
all pts receiving gastric resection for cancer, with anastomosis
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDIGS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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