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临床试验/NL-OMON33359
NL-OMON33359已完成不适用

Single step treatment using radiofrequency ablation and endoscopic resection for Barrett esophagus containing early neoplasia . - Radiofrequency ablation and endoscopic resection: one treatment

Academisch Medisch Centrum0 个研究点目标入组 20 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
已完成
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Age 18-85 years;
  • - Minimum circumferential extent of Barrett's of 2cm prior to treatment
  • - Endoscopic visible abnormality of type 0-I,0-IIa, 0-IIc or a combination therof.
  • - Biopsy proven High grade dysplasia (HGD) or Early cancer (EC) on two seperate endoscopic sampling procedures.
  • - Written informed consent

排除标准

  • 1. Barrett's extent of >12cm
  • 2. Any prior endoscopic treatment for esophageal adenocarcinoma of BE associated neoplasia.
  • 3. Signs of local or distant metastasis on EUS (EUS is obligatory).
  • 4. Signs of distant metastasis on CT-scan of thorax and/or abdomen (optional for mucosal lesions).
  • 5. Any of the following findings in any of the ER specimens: G3 or G4 tumor differentiation; lymphatic invasion; infiltration into the submucosa >500µm, a positive deeper resection margin.
  • 6. Endoscopic signs of esophageal varices.
  • 7. Esophageal stenosis not allowing passage of a therapeutic endoscope with an ER-cap.
  • 8. Prior esophageal surgery (except fundoplication).
  • 9. Use of any anticoagulant therapy that can not be discontinued between one week before and 1 week after every treatment session.

研究者

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