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Procalcitonin Reveals Early Dehiscence in Gastric Surgery: the PREDIGS Study

NCT ID: NCT02756455

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. Gastric cancer surgery is associated with high risk for 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. Investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after gastric surgery

Detailed Description

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Conditions

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Gastric Cancer

Keywords

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gastric cancer procalcitonin

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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gastric cancer pts undergoing surgery

all pts receiving gastric resection for cancer, with anastomosis

gastric cancer pts undergoing surgery

Intervention Type OTHER

Measure PCT (procalcitonin), CRP (C-reactive protein) and WBC (white blood cell count) in 3rd and 5th postoperative day and registration of all intra and postoperative complications

Interventions

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gastric cancer pts undergoing surgery

Measure PCT (procalcitonin), CRP (C-reactive protein) and WBC (white blood cell count) in 3rd and 5th postoperative day and registration of all intra and postoperative complications

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients undergoing all different kinds of gastric surgery (from partial to total gastrectomy) for cancer, WITH an anastomosis performed
* elective setting

Exclusion Criteria

* age \< 18 years
* pregnant women
* patients undergoing gastric surgery for benign disease or other kinds of gastric 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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PREDIGS

Identifier Type: -

Identifier Source: org_study_id