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Completed

NCT Number: NCT03973736

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

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.

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma

Age range

Up to 85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda USL - IRCCS di Reggio Emilia

Reggio Emilia, 42123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)

Other

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

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

Acronym: RevRadPAC

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 4, 2019
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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