DRKS00006114已完成未知
Hybrid APC Argon-Plasma-Coagulation Technique for the Therapy of Barrett's Esophagus With Low-grade and High-grade Neoplasia or After Primary Endoscopical Resection of Premature Neoplasia - Hybrid-APC
Sanaklinikum Offenbach0 个研究点目标入组 164 人开始时间: 2014年5月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Patients with secondary neoplastic Barrett's esophagus after successful EMR of visual lesions/ carcinoma whose endotherapy shall be continued. Histologically maximum high grade intraepithelial neoplasia with Barrett's length of = 1 cm und = 10 cm (Prague classification) without visual neoplasia. Any Patient with EMR not longer ago than 6 month and no ablative theray may be included
- •Patients without visual lesions, thoroughly endoscoped (HD-endoscopy, acetic acid staining) and by second look approved low grade intraepithelial neoplasia (LGIN), who are supposed to get Hybrid APC as primary therapy
- •Patients without visual lesions, thoroughly endoscoped (HD-endoscopy, acetic acid staining) and by second look approved high grade intraepithelial neoplasia (HGIN), who are supposed to get Hybrid APC as primary therapy according to discretion of examiner
- •signed Informed Consent
排除标准
- •proof of Adenocarcinoma with submucosal Infiltration in EMR supplement
- •no total ablation of Barrett's mucosa planned
- •Patients who are planned to have a total or more than 80% of the Barrett's extension EMR once or more often
- •insufficient previous therapy outcome after 3 EMR procedures, e.g. insufficient ER with required re-EMR
- •missing re-epithelisation after initial EMR as a sign of disrupted healing process
- •status post any ablative therapy, e.g. APC, RFA
- •Barrett's esophagus without proven neoplasia or dysplasia
- •length of Barrett's esophagus >10 cm (Prague-classification, C-measurement)
- •therapy-resistant stenosis (not passable with therapeutic endoscope) after EMR
- •Any not curatively treated or not treatable secondary tumors
- •Patients with severe general diseases (resisting American Society of Anesthesiologists Classification (ASA) III/IV, dialysis) who will prognostically not profit by the therapy, expectancy of life < 1 year
- •Patients with known coagulopathy or anticoagulants other than acetylsalicylic acid
- •esophageal varicosis
- •missing Informed Consent
研究者
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