Comparative Study of Anchoring-tip vs. Conventional EMR of Intermediate-Size Colorectal Polyps: Multi-center, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Primary outcome was comparing the R0 resection rate between Anchoring-tip EMR and Conventional EMR.
研究概览
简要总结
Endoscopic mucosal resection (EMR) is an effective and has been widely used technique for the treatment of superficial colorectal neoplasms. Although, conventional EMR (CEMR) showed high efficacy for the management of colorectal superficial neoplasms, there is problematic limitation in this technique - incomplete resection. In literature, the anchoring-tip EMR (AEMR), named as "Tip-in EMR" was first introduced in 2016 from Japan. Recently, several retrospective studies have been suggested about the effectiveness of AEMR. However, there has been no prospective randomized controlled study to identify its advantage over CEMR. Therefore, the investigators performed a multicenter randomized controlled trial to estimate the effectiveness of AEMR compared with CEMR for the endoscopic treatment of intermediate-size (10 to 20 mm) colorectal polyps.
详细描述
After injection of normal saline solution mix, snaring was tried for CEMR. In AEMR, the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins. At the final step of both conventional and Tip-in EMR, the lesion was resected.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Intermediate-size (10 to 20 mm) colorectal polyps
- •Morphologically sessile (Is), slightly elevated (IIa), flat (IIb), and slightly depressed (IIc) as Paris classification of superficial neoplastic lesions
- •Laterally spreading tumor (granular and nongranular type) as Kudo classification.
排除标准
- •Pedunculated or excavated/ulcerated polyps
- •Polyps with features strongly suggestive of submucosal invasive carcinoma
- •Polyps in patients with inflammatory bowel disease, familial polyposis, electrolyte abnormality, and coagulopathy
- •Residual lesions after endoscopic resection or presence of severe submucosal fibrosis.
结局指标
主要结局
Primary outcome was comparing the R0 resection rate between Anchoring-tip EMR and Conventional EMR.
时间窗: From EMR to reporting of histopathology, 1 month
Histopathologic complete resection (R0) was defined as en bloc resection and clear lateral and vertical resection margins.
次要结局
未报告次要终点
研究者
Joon Seop Lee
Clinical Assistant Professor
Kyungpook National University Chilgok Hospital