Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study

NCT02756468 | Unknown DMC

• 1 other identifier: PREDIPS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; procalcitonin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• PCT and CRP cuts-off in 3rd POD with a good NPV for AL

  2 yrs

• PCT and CRP cuts-off in 5th POD with a good NPV for AL

  2 yrs

Study Arms (1)

pts operated for pancreatic cancer

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

Other: pts operated for pancreatic cancer

Interventions

pts operated for pancreatic cancer OTHER

measuring CRP and PCT in 3rd and 5th POD after pancreatic cancer resection

pts operated for pancreatic cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all pts undergoing pacreatic resections for cancer

You may qualify if:

• patients undergoing all different kinds of pancreatic surgery
• in elective setting
• for cancer
• with a pancreatic anastomosis performed.

You may not qualify if:

• age \< 18 years
• pregnant women
• patients undergoing pancreatic surgery for benign disease, other kinds of pancreatic surgery without an anastomosis being performed

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sant'Andrea University Hospital

Rome, 00189, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Valentina Giaccaglia, MD

CONTACT

+393397882429; v.giaccaglia@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 29, 2016
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 29, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)