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

Pancreatic Ductal Adenocarcinoma Clinical Trial

— RevRadPAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973736
• Other study ID #: 286/2018/OSS/AUSLRE
• Status: Completed
• Start date: June 15, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: June 2019
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: January 15, 2019
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

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.

Locations

Country	Name	City	State
Italy	Azienda USL - IRCCS di Reggio Emilia	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	overall survival (restricted to patients with at least 24 months follow-up)	24 months
Secondary	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