Clinical trial NCT03973736: Impact of Multidisciplinary and Radiologic Review on Outcome of Pancreatic Cancer Patients: an Observational Study
Official title: Impatto Della Revisione Radiologica Con Valutazione Multidisciplinare Nella Gestione Terapeutica Dei Pazienti Affetti da Adenocarcinoma Pancreatico (PAC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2019-06-04
Enrollment: 316
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Reggio Emilia Pancreatic Cancer Register registered 1157 PDAC cases from 2008 to 2016. After exclusion of cases diagnosed in 2012, patients aged \>85 years and cancer staged as IV or with unknown stage, a total of 132 and 184 patients were included in analysis respectively for 2008-2011 and 2013-2016 periods.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of surgical failures on the total of eligible patients
timeFrame: immediately after surgery
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: proportion of patients referred to different therapeutic options
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Azienda USL - IRCCS di Reggio Emilia
Study officials:
References: