Impact of Multidisciplinary and Radiologic Review on Outcome of Pancreatic Cancer Patients: an Observational Study

NCT ID: NCT03973736

Last Updated: 2019-06-04

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

316 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-15

Study Completion Date

2019-01-15

Brief Summary

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The investigators compared two different time periods respectively before and after the application of a dedicated diagnostic and therapeutic protocol for pancreatic ductal adenocarcinoma including multidisciplinary discussion and radiological review of cases, in order to evaluate the impact of the new protocol on surgical failures and overall survival.

Detailed Description

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Since 2012 in Reggio Emilia a new diagnostic and therapeutic protocol has been implemented including multidisciplinary team discussion of non-metastatic PDACs and radiological review of CT scans by an experienced radiologist.

The aim of this study is to measure the impact of this new protocol on the occurrence of surgical failures, including incomplete resection or surgery in which resection resulted impossible at all. The investigators also describe the changes in overall survival and process indicators such as the proportion of patients referred to different therapeutic options (upfront surgery, neoadjuvant chemotherapy and no surgery) and the compliance with referral.

Through a population-based cohort study, the investigators evaluated the impact of the new protocol on therapeutic management and surgical outcome of patients with non-metastatic PDAC by comparing two four-years periods, respectively 2008-2011 and 2013-2016, before and after the introduction of the protocol. Since 2012 was the transitional year when the protocol was introduced, patients diagnosed with PDAC in 2012 were excluded.

Conditions

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Pancreatic Ductal Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PDAC patients diagnosed in 2008-2011

No interventions assigned to this group

PDAC patients diagnosed in 2013-2016

application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)

Intervention Type OTHER

Since the introduction of the new protocol in 2012, a single central multidisciplinary team has been formalized, with weekly discussion of cases, including different specialists from all the provincial hospitals. CT scans of discussed cases are reviewed by one of two experienced radiologists based on pre-defined criteria.

Interventions

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application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)

Since the introduction of the new protocol in 2012, a single central multidisciplinary team has been formalized, with weekly discussion of cases, including different specialists from all the provincial hospitals. CT scans of discussed cases are reviewed by one of two experienced radiologists based on pre-defined criteria.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* all consecutive inhabitants of the Reggio Emilia province with incident PDACs in 2008-2011 and 2013-2016 periods

Exclusion Criteria

* pancreatic cancers with cytohistological diagnosis different from PDAC,
* diagnosis in 2012,
* metastatic disease at diagnosis (stage IV) or unknown stage at diagnosis,
* patients aged \>85 years.
Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda USL - IRCCS di Reggio Emilia

Reggio Emilia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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286/2018/OSS/AUSLRE

Identifier Type: -

Identifier Source: org_study_id

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