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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
Sponsor:
Information provided by (Responsible Party):
Azienda Unità Sanitaria Locale Reggio Emilia

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.

Condition or disease Intervention/treatment
Pancreatic Ductal Adenocarcinoma 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.


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Study Type : Observational
Actual Enrollment : 316 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]
    overall survival (restricted to patients with at least 24 months follow-up)

  2. 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)



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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

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


Locations
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Italy
Azienda USL - IRCCS di Reggio Emilia
Reggio Emilia, Italy, 42123
Sponsors and Collaborators
Azienda Unità Sanitaria Locale Reggio Emilia

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Responsible Party: Azienda Unità Sanitaria Locale Reggio Emilia
ClinicalTrials.gov Identifier: NCT03973736     History of Changes
Other Study ID Numbers: 286/2018/OSS/AUSLRE
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms