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Clinical Trials/NCT03973736
NCT03973736CompletedNot Applicable

Impatto Della Revisione Radiologica Con Valutazione Multidisciplinare Nella Gestione Terapeutica Dei Pazienti Affetti da Adenocarcinoma Pancreatico (PAC)

Azienda Unità Sanitaria Locale Reggio Emilia1 site in 1 country316 target enrollmentStarted: June 15, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
316
Locations
1
Primary Endpoint
Proportion of surgical failures on the total of eligible patients

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
— to 85 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Proportion of surgical failures on the total of eligible patients

Time Frame: immediately after surgery

proportion of patients with incomplete resection or who received surgery in which resection was not possible

Secondary Outcomes

  • proportion of patients referred to different therapeutic options(up to 1 year)
  • Overall survival(24 months)

Investigators

Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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