Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 2865 for:    Pancreatic Cancer AND pancreas

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02756468
Recruitment Status : Unknown
Verified April 2016 by Valentina Giaccaglia, University of Roma La Sapienza.
Recruitment status was:  Recruiting
First Posted : April 29, 2016
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Valentina Giaccaglia, University of Roma La Sapienza

Brief Summary:

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


Condition or disease Intervention/treatment
Pancreatic Cancer Other: pts operated for pancreatic cancer

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study
Study Start Date : January 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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. 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


Secondary Outcome Measures :
  1. 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. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all pts undergoing pacreatic resections for cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756468


Contacts
Layout table for location contacts
Contact: Valentina Giaccaglia, MD +393397882429 v.giaccaglia@gmail.com

Locations
Layout table for location information
Italy
Sant'Andrea University Hospital Recruiting
Rome, Italy, 00189
Contact: Valentina Giaccaglia, MD    00393397882429    v.giaccaglia@gmail.com   
Principal Investigator: Valentina Giaccaglia, MD         
Sponsors and Collaborators
University of Roma La Sapienza

Additional Information:

Layout table for additonal information
Responsible Party: Valentina Giaccaglia, MD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02756468     History of Changes
Other Study ID Numbers: PREDIPS
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Valentina Giaccaglia, University of Roma La Sapienza:
pancreatic cancer
procalcitonin
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases