Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation or Argon Plasma Coagulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 10
- 主要终点
- Recurrence
研究概览
简要总结
Patients who have provided informed consented and are scheduled to undergo endoscopic mucosal resection (EMR) of lesions 15mm and larger will be randomized to STSC (80 W, Effect 5) vs APC (preferred settings) vs No Treatment of the perimeter of the EMR site.
详细描述
Data regarding polyp morphology, location & shape will be recorded in addition to procedure and treatment length. Injection fluid use and clipping will also be recorded in addition to any procedural complications.
All randomized subjects will receive a 30-day post procedure follow-up phone call and be scheduled, as per the standard of care, to receive a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the rate of recurrence by endoscopic visualization of the EMR site at the first follow-up using endoscopic magnification and electronic chromoendoscopy, as well as systematic biopsy of the scars.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25 years and older
- •Ability to provide informed consent
- •Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion
排除标准
- •Pedunculated lesions
- •Inflammatory bowel disease
- •Inability to provide informed consent
- •Lesions less than 15mm in largest dimension
研究组 & 干预措施
Argon Plasma Coagulation
Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added.
干预措施: Argon Plasma Coagulation (Device)
Snare Tip Soft Coagulation
Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added.
干预措施: Snare Tip Soft Coagulation (Device)
No treatment
Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI.
结局指标
主要结局
Recurrence
时间窗: 1 day
The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy
Types of Recurrences
时间窗: 1 day
Description of whether recurrence was visible during the follow-up procedure and confirmed by pathology, visible during the follow-up procedure but not confirmed by pathology, or not visible during the follow-up procedure but confirmed by pathology of biopsies taken.
次要结局
- Complications(1 day)
- Time(1 day)
研究者
Douglas K. Rex
Principal Investigator
Indiana University