"Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis. Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Macroscopically complete resection rate
研究概览
简要总结
All procedures are performed in the investigator's outpatient gastroenterology and digestive endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower intestinal tract.
Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion the lumen will be completely decompressed with aspiration of the gas, and then again relaxed with the instillation of only water. The EleviewTM will be injected into the submucosa in such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic evidence of complete resection. All the removed material will be stored and sent to histological analysis. Tolerability score will be recorded during the procedure.
Any "bleeding" (both intra- and post-procedural), perforation, post-polypectomy syndrome, stenosis or death in the 6 months following the procedure will be born "complication".
A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months after the procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years.
- •Signing of informed consent.
- •Possibility of being subjected to the diagnostic and therapeutic procedures of the study.
- •Presence of colo-rectal polypoid lesions ≥ 15mm presenting macroscopic aspects of fibrosis as a consequence of previous incomplete treatments or biopsies or relapses after previous removal.
排除标准
- •Highly indicative morphological characteristics of carcinoma with submucosal invasion (Ulceration, Pit Pattern Vn according to Kudo et al.18)
- •Pregnancy or breastfeeding
- •Unstable personality or unable to adhere to the protocol procedures.
- •Inability to provide informed consent.
- •Injury not reachable endoscopically.
结局指标
主要结局
Macroscopically complete resection rate
时间窗: 6 Months
6-month recurrence rate;
时间窗: 6 Months
Rate of adverse events (according to the lexiconA ASGE).
时间窗: 6 Months
次要结局
未报告次要终点
