Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study (PREDIPS)

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

Background. Pancreatic cancer surgery is associated with very high risk of 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. The investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after pancreatic 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 pts undergoing pacreatic resections for cancer

Description

Inclusion Criteria:

  • patients undergoing all different kinds of pancreatic surgery
  • in elective setting
  • for cancer
  • with a pancreatic anastomosis performed.

Exclusion Criteria:

  • age < 18 years
  • pregnant women
  • patients undergoing pancreatic surgery for benign disease, other kinds of pancreatic 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
pts operated for pancreatic cancer
all pts operated of pancreatic resection for cancer in the involved units
Other: pts operated for pancreatic cancer
measuring CRP and PCT in 3rd and 5th POD after pancreatic cancer resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery
Time Frame: 2 yrs
Sensitivity: % of patients corrected identified by the biomarkers having AL; PCT: procalcitonin, CRP: C-reactive protein, AL: anastomic leak
2 yrs
Specificity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery
Time Frame: 2 yrs
Specificity: % of pts corrected identified by the biomarkers not having AL; PCT: procalcitonin, CRP: C-reactive protein, AL: anastomic leak
2 yrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCT and CRP cuts-off in 3rd POD with a good NPV for AL
Time Frame: 2 yrs
PCT: procalcitonin, CRP: C-reactive protein, NPV: negative predictive value
2 yrs
PCT and CRP cuts-off in 5th POD with a good NPV for AL
Time Frame: 2 yrs
PCT: procalcitonin, CRP: C-reactive protein, NPV: negative predictive value
2 yrs

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

  • PREDIPS

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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