A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM (LR) as a Modified Colonic Overtube
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Length of time required to remove large and flat colonic polyps
研究概览
简要总结
Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in 2010 and worldwide has become the third most common cancer and second leading cause of cancer related deaths. Colonic adenomatous polyps are known precursors of colorectal cancer and endoscopic removal of the polyps prevents development of colon cancer.
Removal of such large polyps requires special endoscopic techniques-endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), which are more technically difficult to perform, labor intensive, time consuming and carries higher risks of complications (bleeding, perforations, etc.). The purpose of this study is to determine the effectiveness and safety of the LumenR Retractor in performing EMR and ESD. It is hypothesized that the use of this modified colonic overtube will simplify colonoscopic removal of difficult polyps, decrease the time needed to complete the procedure and decrease the rate of complications post endoscopic removal of large and flat colonic.
详细描述
All patients presented for endoscopic removal of difficult colonic polyps will be eligible for the study based on inclusion and exclusion criteria. All procedures will be explained by the Investigator and all subjects undergoing treatment will review and sign the study Informed Consent prior to the procedure. Each subject will be randomly assigned to two groups, Group 1 and Group 2, and according to the assignment, the LumenR Retractor will be used or not during the procedure.
Patient preparation, including intravenous sedation, will be the same for both Groups.
Group 1: A traditional pediatric colonoscope will be advanced into the colon and endoscopic removal of the polyp will be performed.
Group 2: A traditional pediatric colonoscope with a modified overtube preloaded over the endoscope will be advanced into the colon. After the polyp is reached, the overtube will be advanced forward and expanded around the polyp. Endoscopic removal of the polyp with the use of commercially available graspers and biopsy forceps inserted through the overtube working channels will be performed.
At the conclusion of each procedure, the size of the polyp, total procedure time, amount of CO2 used for colonic insufflation, amount of fluid used for submucosal injection, and any complications, including bleeding and perforation, will be recorded. At the end of the procedure, if necessary, the resulting mucosal defect after lesion removal will be closed with endoscopic clips or endoscopic suturing device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colonic polyps 2cm in size or greater
- •Subject 17 to 90 years of age
- •Female subjects must have negative pregnancy test within last 24 hours timeline, and no intentions to become pregnant or be sterilized during participation in study.
排除标准
- •Colonic polyps less than 2cm in size
- •Under 17 or over 90 years of age
- •Unwilling to consent or comply with protocol requirements
- •Uncorrectable bleeding disorders (INR more than 1.5; platlet count less than 50,000)
- •Allergy to materials from which the device is constructed- Polyvinyl Chloride, Nitinol, Watershed, Polycarbonate, and Polytetrafluoroethylene
- •Received experimental drug or device within 3 months prior to start of study
- •Treatment with an investigational drug or medical device during the study period
- •Female subjects that are pregnant or lactating or intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study
- •Psychological condition, or under treatment for any condition which, in the opinion of the Investigator and/or consulting physician(s), would constitute an unwarranted risk
研究组 & 干预措施
Removal without overtube
Endoscopic removal of polyp without overtube
干预措施: Removal without overtube (Device)
LumenR Retractor
Endoscopic removal of polyp using modified overtube LumenR Retractor
干预措施: LumenR Retractor (Device)
结局指标
主要结局
Length of time required to remove large and flat colonic polyps
时间窗: Day 1
Percentage of successful en block removal of polyps
时间窗: 1 year
次要结局
- Amount of solution used for submucosal injection to lift the polyp(Day 1)
- Amount of carbon dioxide (CO2) gas for colonic insufflation used during procedure(Day 1)
- Rate of bleeding during polypectomy(1 year)
- Presence of residual polypoid tissue at the site of polypectomy(3 months)
- Rate of perforation during polypectomy(1 year)
- Safety assessment based on the number of delayed adverse events and complications(10 days)
研究者
Sergey Kantsevoy
Director of Therapeutic Endoscopy
Mercy Medical Center