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临床试验/NCT03973736
NCT03973736已完成不适用

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

Azienda Unità Sanitaria Locale Reggio Emilia1 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2018年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
316
试验地点
1
主要终点
Proportion of surgical failures on the total of eligible patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all consecutive inhabitants of the Reggio Emilia province with incident PDACs in 2008-2011 and 2013-2016 periods

排除标准

  • 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.

结局指标

主要结局

Proportion of surgical failures on the total of eligible patients

时间窗: immediately after surgery

proportion of patients with incomplete resection or who received surgery in which resection was not possible

次要结局

  • proportion of patients referred to different therapeutic options(up to 1 year)
  • Overall survival(24 months)

研究者

发起方
Azienda Unità Sanitaria Locale Reggio Emilia
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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