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临床试验/NCT04901364
NCT04901364Unknown不适用

Sensitivity and Specificity Study of Risk Factors for Intraductal Papillary Mucinous Neoplasms Degeneration at the Nancy CHRU (IPMN)

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年5月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
57
试验地点
1
主要终点
High-grade dysplasia or invasive cancer

研究概览

简要总结

Cystic lesions of the pancreas are frequent with a risk of degeneration into adenocarcinoma with pejorative prognosis.

IPMNs require characterization to clarify their potential for degeneration. Clinical and morphological risk factors for degeneration determine the monitoring rate and the indication for pancreatic surgery.

Pancreatic surgery remains invasive with high morbidity and mortality rates.

详细描述

This is a monoservice and monocentric retrospective study at the Nancy CHRU. We will study the risk factors for IPMNs degeneration in order to determine the most sensitive and specific.

To do this, we will use high-grade dysplasia or invasive cancer on the histological analysis of surgical specimens as the primary endpoint.

The study population will be patients with Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021, adults and without legal protection measures

排除标准

  • IPMNs not operated
  • Pancreatic cancer without IPMNs
  • Patients whose state of health contraindicates pancreatic surgery
  • Non-adult patient
  • Patients under legal protection

结局指标

主要结局

High-grade dysplasia or invasive cancer

时间窗: 12 years

High-grade dysplasia or invasive cancer on histological analysis of the surgical specimen

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Baptiste CHEVAUX

PH

Central Hospital, Nancy, France

研究点 (1)

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