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临床试验/NCT03546998
NCT03546998招募中不适用

Incidence and Risk Factors for Development of Epidermoid Carcinoma in Esophageal Achalasia

Sandro Mattioli1 个研究点 分布在 1 个国家目标入组 681 人开始时间: 2018年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
681
试验地点
1
主要终点
Detection of epidermoid carcinoma of the esophagus

研究概览

简要总结

Esophageal achalasia is a precancerous condition for epidermoid carcinoma; incidence and risk factors for cancer development are not defined. Incidence and risk factors for epidermoid carcinoma development in achalasia patients were investigated.

详细描述

In order to define incidence and risk factors for epidermoid carcinoma 681 patients affected by esophageal achalasia observed since 1973 were followed up with no time limits according to a prospective follow-up protocol. The local institutional review board approved using the database from the division of thoracic surgery for research purposes. Clinical, radiological and endoscopic data of achalasia patients were collected and analyzed.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • diagnosis of primary esophageal achalasia achieved by means of radiology, endoscopy and manometry

排除标准

  • pseudoachalasia

结局指标

主要结局

Detection of epidermoid carcinoma of the esophagus

时间窗: 1 year

Detection of epidermoid carcinoma of the esophagus by means of upper GI endoscopy

次要结局

  • Result of achalasia treatment by investigating dysphagia and gastro-esophageal reflux(1 year)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sandro Mattioli

Prof. Sandro Mattioli

University of Bologna

研究点 (1)

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