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2015-01
2016-06
2016-12
100
NCT02756468
University of Roma La Sapienza
University of Roma La Sapienza
OBSERVATIONAL
Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study
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
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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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-04-18 | N/A | 2016-04-28 |
2016-04-28 | N/A | 2016-04-29 |
2016-04-29 | N/A | 2016-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
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Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Sensitivity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery | 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 | 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 | Measure Description | Time Frame |
|---|---|---|
| PCT and CRP cuts-off in 3rd POD with a good NPV for AL | 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 | PCT: procalcitonin, CRP: C-reactive protein, NPV: negative predictive value | 2 yrs |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Valentina Giaccaglia, MD Phone Number: +393397882429 Email: v.giaccaglia@gmail.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
