- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02756468
Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study (PREDIPS)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Rome, Italy, 00189
- Recruiting
- Sant'Andrea University Hospital
-
Contact:
- Valentina Giaccaglia, MD
- Phone Number: 00393397882429
- Email: v.giaccaglia@gmail.com
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Principal Investigator:
- Valentina Giaccaglia, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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