Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study

• Conditions: Pancreatic Cancer
• Interventions: Other: pts operated for pancreatic cancer

• Registration Number: NCT02756468
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Status Verified: 2016-04
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-28
• Last Update Submitted: 2016-04-28
• Study First Posted: 2016-04-29
• Last Update Posted: 2016-04-29
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pts operated for pancreatic cancer	pts operated for pancreatic cancer	all pts operated of pancreatic resection for cancer in the involved units

Primary Outcome Measures

Name	Time	Method
Sensitivity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery	2 yrs	Sensitivity: % of patients corrected identified by the biomarkers having AL; PCT: procalcitonin, CRP: C-reactive protein, AL: anastomic leak
Specificity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery	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

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

Trial Locations

Locations (1)

Sant'Andrea University Hospital; 🇮🇹 Rome, Italy