Complete Removal of Neoplastic Large Colorectal Polyps: a Prospective Randomized Comparison of Endoscopic Mucosal Resection or Conventional Polypectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The incomplete resection rate of neoplastic polyps as determined by the histopathologic examination.
研究概览
简要总结
Recently, it was reported that the incomplete resection rate of neoplastic large polyps after conventional polypectomy was markedly high in clinical practice. The incomplete resection rate of neoplastic large polyps after endoscopic mucosal resection (EMR) is not known.
The aim of this study is to compare the incomplete resection rate of neoplastic large polyps after EMR or conventional polypectomy. The EMR technique is preferable to conventional polypectomy for the complete resection of the large polyps (>15 mm in diameter)
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria were nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter.
排除标准
- •less than 20 years old, history of previous colorectal surgical resection, American Society of Anesthesiologists class III and IV, allergic to propofol used or its components (soybeans or eggs), or poor bowel preparation.
研究组 & 干预措施
Conventional polypectomy
Colorectal polyps from 10 mm to 25 mm was found. Submucosal injection of saline solution before removal was not performed for polypectomy. The snare used for polypectomy was a dual loop wire snare with a loop size of 33/16 mm (SN-3316LX, Medico's Hirata Inc., Osaka, Japan). An ERBE ICC200 (Amco, Tokyo, Japan) was used in the Endocut mode with the effect 3 current set at output limit 120W and forced coagulation current set at output limit 35W for conventional polypectomy. Prophylactic clipping after polyp removal was routinely performed.
干预措施: Conventional polypectomy (Procedure)
Endoscopic mucosal resection
Colorectal polyp from 10 mm to 25 mm was found. Submucosal injection of saline solution before removal was performed for EMR. The snare used for EMR was a dual loop wire snare with a loop size of 33/16 mm (SN-3316LX, Medico's Hirata Inc., Osaka, Japan). An ERBE ICC200 (Amco, Tokyo, Japan) was used in the Endocut mode with the effect 3 current set at output limit 120W and forced coagulation current set at output limit 35W for EMR. Prophylactic clipping after polyp removal was routinely performed.
干预措施: Endoscopic mucosal resection (Procedure)
结局指标
主要结局
The incomplete resection rate of neoplastic polyps as determined by the histopathologic examination.
时间窗: Two weeks
次要结局
- Postpolypectomy bleeding requiring endoscopic intervention within two weeks after polypectomy(Two weeks)
研究者
Akira Horiuchi
Chief, Digestive Disease Center
Showa Inan General Hospital