Usefulness of Narrow Band Imaging (NBI) for Complete Endoscopic Resection of Sessile Serrated Adenoma/Polyp (SSA/P): NASA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 主要终点
- The diagnosis rate of SSA/P in the remnant tissue
研究概览
简要总结
This study is a prospective randomized study to evaluate the role of NBI for improving complete resection rate of sessile serrated adenoma/polyp (SSA/P). The authors will enroll consecutive patients who underwent colon polypectomy for SSA/P during colonoscopy. The authors will inspect resection margin of SSA/P using white light endosocpy (WLE) or NBI after randomization for the evaluation of remnant lesion. Additional resection will be performed for suspicious of remnant lesion, and then 4 biopsies from 4 quadrants of margin for evaluation of complete resection.
详细描述
This study is a prospective randomized multi-center study to evaluate the role of NBI for improving complete resection rate of sessile serrated adenoma/polyp (SSA/P).
The authors will enroll consecutive patients who underwent colon polypectomy for suspicious SSA/P during colonoscopy.
All patients who undergo polypectomy will be enrolled, but excluded as follows; 1. poor bowel preparation according to Boston bowel preparation scale calculation, 2. inflammatory bowel disease, 3. failure of cecal insertion, 4. continuous anti-plate agents or anti-coagulation agents users.
First, the authors will inspect polyp using the arbitrary endoscopic criteria by inspection of white light endoscopy (WLE) and if that lesion is satisfied with 3 or more than 3 out of 5 categories (1. located in the right colon, 2. flat shape, 3. covered with mucus cap or debris, 4. 1 cm or larger than 1 cm in size, 5. varicose superficial vessel was seen on the surface after submucosal injection), endoscopic resection will be performed.
And then, the authors will inspect the resection margin carefully using NBI or WLE by pre-randomization before endoscopic resection. If the remnant tissue is detected, additional endoscopic resection will be performed.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Colonoscopy examinee with suspicious SSA/P
排除标准
- •Poor bowel preparation (total Boston bowel preparation scale < 6 or any region score < 2)
- •Inflammatory bowel disease
- •failed cecal insertion of colonoscopy
- •continuous taking anticoagulation or anti-platelet drugs until on the procedure day
研究组 & 干预措施
NBI
The group of NBI inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed.
干预措施: Endoscopy using Narrow band imaging (Other)
White light endoscopy (WLE)
The group of WLE inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed.
结局指标
主要结局
The diagnosis rate of SSA/P in the remnant tissue
时间窗: 2 years after IRB
Pathologic diagnosis rate of SSA/P after the additional endoscopic resection of the remnant tissue detected by NBI or WLE right after the endoscopic resection.
Incomplete resection rate of SSA/P
时间窗: 2 years after IRB
Compare the incomplete resection rate of SSA/P using four directional biopsied on the resection margin after the endoscopic resection including additional resection
the detection rate of remnant lesion,
时间窗: 2 years after IRB
Comparing the detection rate of remnant SSA/P right after the endoscopic resection
次要结局
- Accuracy of arbitrary endoscopic criteria for SSA/P inspection by white light endoscopy(2 years after IRB)
研究者
Hyun Gun, Kim. M.D., Ph.D.
Associate professor
Soonchunhyang University Hospital