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Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study

NCT ID: NCT02756468

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Pancreatic Cancer

Keywords

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pancreatic cancer procalcitonin

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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pts operated for pancreatic cancer

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

pts operated for pancreatic cancer

Intervention Type OTHER

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

Interventions

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pts operated for pancreatic cancer

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Valentina Giaccaglia

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sant'Andrea University Hospital

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Valentina Giaccaglia, MD

Role: CONTACT

Phone: +393397882429

Email: [email protected]

Facility Contacts

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Valentina Giaccaglia, MD

Role: primary

Other Identifiers

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PREDIPS

Identifier Type: -

Identifier Source: org_study_id