Impact of Multidisciplinary and Radiologic Review on Outcome of Pancreatic Cancer Patients: an Observational Study (RevRadPAC)
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|ClinicalTrials.gov Identifier: NCT03973736|
Recruitment Status : Completed
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment|
|Pancreatic Ductal Adenocarcinoma||Other: application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)|
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|
|Actual Enrollment :||316 participants|
|Official Title:||Impatto Della Revisione Radiologica Con Valutazione Multidisciplinare Nella Gestione Terapeutica Dei Pazienti Affetti da Adenocarcinoma Pancreatico (PAC)|
|Actual Study Start Date :||June 15, 2018|
|Actual Primary Completion Date :||July 15, 2018|
|Actual Study Completion Date :||January 15, 2019|
|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.
- 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
- Overall survival [ Time Frame: 24 months ]overall survival (restricted to patients with at least 24 months follow-up)
- proportion of patients referred to different therapeutic options [ Time Frame: up to 1 year ]proportion of patients referred to different therapeutic options (upfront surgery, neoadjuvant chemotherapy and no surgery)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973736
|Azienda USL - IRCCS di Reggio Emilia|
|Reggio Emilia, Italy, 42123|