Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 990
- 试验地点
- 1
- 主要终点
- Severe Adverse Events
研究概览
简要总结
This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without electrocautery ("cold" snare EMR). The second randomization will assign half of patients to polyp removal using Eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.
详细描述
Electrocautery, or hot snare resection has long been considered the standard approach to polyp resection. A major limitation is a 5 to 10% risk of major adverse events. Recent studies suggest that snare resection without electrocautery - so-called cold snare EMR - may be safer than hot snare EMR. The concern with cold snare resection is a potentially lower efficacy, because cold snare resection requires the removal of a large polyp in smaller and greater number of pieces than with hot snare resection. This may lengthen procedure time and increase the risk of incomplete resection.
Furthermore, there is uncertainty about the optimal injection solution for lifting of the polyp prior to resection. Normal saline with methylene blue as the contrast agent is frequently used, but is limited by fast dissipation of the polyp lift. Eleview is a newly approved viscous solution (that contains methylene blue), which provides a longer polyp lift than normal saline. It is unclear how these two solutions compare with respect to resection efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization 1 (Cold vs. hot snare group): Masking only of participants Randomization 2 (Eleview vs Placebo): Masking of all checked above
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
- •Any patient ≥18 who presents for a colonoscopy and who does not have criteria for exclusion
- •Patients with a ≥20mm non-pedunculated colorectal polyp
排除标准
- •Pedunculated polyps (as defined by Paris Classification type Ip)
- •Suspected adenocarcinoma with deep submucosal invasion
- •Patients with ulcerated depressed lesions (as defined by Paris Classification type III) or confirmed adenocarcinoma
- •Patients with inflammatory bowel disease
- •Patients who are receiving an emergency colonoscopy
- •Poor general health (ASA class>3)
- •Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
- •Inadequate bowel preparation (Boston Bowel Prep Scale, total score ≤2)
- •Pregnancy
研究组 & 干预措施
Cold snare & Eleview injection
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview
干预措施: Cold snare EMR (Procedure)
Cold snare & Eleview injection
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview
干预措施: Eleview injection (Procedure)
Cold Snare & Placebo injection
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo
干预措施: Cold snare EMR (Procedure)
Cold Snare & Placebo injection
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo
干预措施: Placebo injection (Procedure)
Hot snare & Eleview injection
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview
干预措施: Hot snare EMR (Procedure)
Hot snare & Eleview injection
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview
干预措施: Eleview injection (Procedure)
Hot snare & Placebo injection
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo
干预措施: Hot snare EMR (Procedure)
Hot snare & Placebo injection
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo
干预措施: Placebo injection (Procedure)
结局指标
主要结局
Severe Adverse Events
时间窗: up to 30 days following the procedure
Aggregate of all severe adverse events that occur at the time of the colonoscopy with resection of the large polyp or following the procedure
次要结局
- Intraprocedural bleeding(at the time of polyp resection)
- Completeness of polyp resection(immediately following polyp resection during the colonoscopy)
- Subcategories of severe adverse events(during the procedure and up to 30 days following the procedure)
- Performance submucosal injectate(immediately following polyp resection during the colonoscopy)
- Polyp recurrence(at surveillance colonoscopies up to 5 years following the initial polyp resection)
- Efficacy of submucosal injectate(immediately following polyp resection during the colonoscopy)
- Volume of submucosal injectate(immediately following polyp resection during the colonoscopy)
- Crossover from cold to hot snare(at the time of polyp resection)
研究者
Dr. Heiko Pohl
Associate Professor or Medicine
White River Junction Veterans Affairs Medical Center