Preoperative Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Pancreatic Fistula After Pancreaticoduodenectomy

NCT ID: NCT04361682

Last Updated: 2020-04-24

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

COMPLETED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-01

Study Completion Date

2020-04-01

Brief Summary

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Particularly, pancreatic fistula is the most common and serious complication after pancreaticoduodenectomy (PD) and is reported in up to 40% of cases. The aim of this retrospective single-center study was to investigate the utility of the combination of preoperative inflammation biomarkers (PIBs) with postoperative day 1 drains amylase (POD1-d.a.) levels in predicting grade C Pancreatic Fistula (PF).

Detailed Description

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Data from a prospective collected database of 317 consecutive PDs performed at the University Campus Bio-Medico di Roma during the years 2005-2019, have been retrospectively analyzed. Local Ethical Committee approved the study.

Patients undergoing PD for periampullary neoplasms were included in the study. All patients underwent to PD with pancreaticojejunostomy reconstruction. Two surgical drains were always placed at the end of the surgery.

Data regarding PIBs, as full blood count including white blood cell (WBC) count, lymphocytes, neutrophils and platelets counts, neutrophil-to-lymphocyte ratio (NLR), derived neutrophil-to-lymphocyte ratio (d-NLR), platelet-to-lymphocyte ratio (PLR) and POD1-d.a. levels were collected and Positive Predictive Values (PPV) and Negative Predictive Values (NPV) were computed to investigate the probability to develop PF combining PIBs and drains amylase values.

Conditions

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Pancreatic Fistula Pancreas Cancer Inflammatory Response

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Surgical Drain Management

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients underwent pancreaticoduodenectomy (PD) for periampullary neoplasms
* Patients underwent PD with pancreaticojejunostomy reconstruction.
* Patient with data of blood count in first postoperative day

Exclusion Criteria

* None of the above criteria
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Damiano Caputo

Associate Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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27/19 OSS ComEt CBM

Identifier Type: -

Identifier Source: org_study_id

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