跳至主要内容
临床试验/NCT03756636
NCT03756636已完成不适用

"Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis. Pilot Study

Istituto Clinico Humanitas2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年6月1日最近更新:
适应症

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

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

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (2)

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