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临床试验/NL-OMON53667
NL-OMON53667招募中不适用

A multicenter prospective cohort study comparing random biopsies with Wide-Area Transepithelial brush-Sampling (WATS) for surveillance of Barrett*s esophagus.;The WATS-EURO2 study - The WATS-EURO2 study

Academisch Medisch Centrum0 个研究点目标入组 239 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
239

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Patients age: >= 18 years
  • - BE with a circumferential extent of >=2cm and a total maximum extent of <=18cm
  • (in case of prior ER: BE length is measured after ER). Or a circumferential
  • extent of 0-1 cm with a maximum extent of >=4cm.
  • - Cohort 1: Patients referred for work-up of IND, LGD, HGD or low-risk cancer
  • (m1 to sm1, without lympho-vascular invasion and poor differentiation), either
  • diagnosed in random biopsies or in prior endoscopic resection specimen within
  • 18 months prior to baseline endoscopy
  • - Cohort 2: Patients with known BE without a diagnosis of dysplasia in the last
  • 18 months, enrolled in endoscopic surveillance programs
  • - Ability to give written, informed consent and understand the responsibilities
  • of participation

排除标准

  • - Patients with visible lesions according to the Paris classification at the
  • time of the WATS and random biopsy testing (prior endoscopic resection is
  • - Patients with high-risk cancer after endoscopic resection: either sm2/3
  • invasion, poor differentiation, lympho-vascular invasion, or R1 vertical
  • resection margin
  • - Patients within six weeks after endoscopy with biopsies and/or ER
  • - History of esophageal or gastric surgery other than Nissen fundoplication
  • - History of esophageal ablation therapy
  • - Presence of esophageal varices
  • - Subject has a known history of unresolved drug or alcohol dependency that
  • would limit ability to comprehend or follow instructions related to informed
  • consent, post-treatment instructions, or follow-up guidelines

研究者

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