NL-OMON24455招募中不适用
Endoscopic Tri-Modal Imaging (ETMI) for the detection of early neoplasia in patients with Barrett’s esophagus (BE) in tertiary referral centers; a randomized cross-over multi-center study.
Academic Medical Center, Amsterdam0 个研究点目标入组 84 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
- 发起方
- 入组人数
- 84
研究概览
简要总结
Curvers WL, Wong Kee Song LM, Wang K, Gostout CJ, Wallace MB, Wolfsen HC, Ragunath R, Fockens P, Bergman JJ. Endoscopic Tri-Modal Imaging (ETMI) for the Detection of Dysplastic Lesions in Barrett's Esophagus; a multi-centre feasibility study. Endosc 2006; 38 (suppl II) A34.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age > 18 years;
- •2. Prior diagnosis of BE defined as the presence of columnar lined epithelium in the tubular esophagus with specialised intestinal metaplasia on histological investigation;
- •3. Prior diagnosis of high-grade dysplasia or early cancer that was endoscopically inconspicuous according to the referring physician. Review of the pathology slides is not required for inclusion;
- •4. A minimum Barrett’s length of C>2M>2 or C<2M>4 according to the Prague C&M classification of the endoscopic appearance of BE;
- •4. Written informed consent.
排除标准
- •1. Presence of active erosive esophagitis > grade A according to the Los Angles classification of erosive esophagitis;
- •2. Description of an endoscopically visible suspicious lesion in the Barrett’s segment in the referring center;
- •3. Presence of conditions precluding histological sampling of the esophagus (e.g. esophageal varices, coagulation disorders, anticoagulant therapy);
- •4. At the first endoscopy: the presence of a type 0-I or type 0-III lesion or a lesion that, according to the discretion of the endoscopist, does not allow a delay in intervention for a period of 6 weeks (interval between the two cross-over endoscopies).
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