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

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.

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

Conditions
-----------------
Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
-----------------
* Other: application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PDAC patients diagnosed in 2008-2011<br> | |
| PDAC patients diagnosed in 2013-2016<br> | Other: application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of surgical failures on the total of eligible patients | proportion of patients with incomplete resection or who received surgery in which resection was not possible | immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | overall survival (restricted to patients with at least 24 months follow-up) | 24 months | 
| proportion of patients referred to different therapeutic options | proportion of patients referred to different therapeutic options (upfront surgery, neoadjuvant chemotherapy and no surgery) | up to 1 year |