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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Other: application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)

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 Type: Observational
• Enrollment (Actual): 316

Contacts and Locations

Study Locations

• Italy
  • Reggio Emilia, Italy, 42123
    • Azienda USL - IRCCS di Reggio Emilia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 85 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PDAC patients diagnosed in 2008-2011
PDAC patients diagnosed in 2013-2016	Other: 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.

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

Collaborators and Investigators

• Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2018
• Primary Completion (ACTUAL): July 15, 2018
• Study Completion (ACTUAL): January 15, 2019

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (ACTUAL): June 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 286/2018/OSS/AUSLRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No