Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study

Pancreatic Cancer Clinical Trial

— PREDIPS  

Official title:

Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02756468
• Other study ID #: PREDIPS
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2016
• Last updated: April 28, 2016
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: University of Roma La Sapienza
• Contact: Valentina Giaccaglia, MD
• Phone: +393397882429
• Email: v.giaccaglia[@]gmail.com
• Is FDA regulated: No
• Health authority: Comitato Etico: 'S. Andrea'
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• pts operated for pancreatic cancer
measuring CRP and PCT in 3rd and 5th POD after pancreatic cancer resection

Locations

Country	Name	City	State
Italy	Sant'Andrea University Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No