Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection: A RandomizeD Trial IN Colorectal Adenomas 10-19mm and Serrated Lesions ≥ 10mm (CARDINAL Study)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 570
- 试验地点
- 2
- 主要终点
- Efficacy of Resection (Central Post-Resection Biopsies)
研究概览
简要总结
The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •≥ 18 years of age
- •Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy
- •Found to have:
- •a sessile serrated lesion or hyperplastic polyp ≥ 10 mm during procedure (Serrated Cohort) or
- •a 10-19 mm conventional adenoma during procedure (Adenoma Cohort)
- •Ability to provide informed consent
排除标准
- •Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- •Polyps confirmed to be anything other than:
- •sessile serrated lesion or hyperplastic polyp on histologic diagnosis (Serrated Cohort) or
- •conventional adenoma on histologic diagnosis (Adenoma Cohort)
- •Patients with Ulcerative Colitis or Crohn's disease
- •Polyps with features suggestive of submucosal invasion
- •Polyps that are not able to be removed endoscopically due to location (e.g. extending into appendiceal orifice or diverticulum)
- •Patients with a known or suspected diagnosis of any of the following polyposis syndromes with known genetic mutations:
- •Familial Adenomatous Polyposis Syndrome
- •MUTYH associated Polyposis Syndrome
- •Juvenile Polyposis Syndrome
- •Cowden's Syndrome
- •Peutz-Jeghers Syndrome
- •Subjects whose colonoscopy procedure is not able to be completed due to bowel prep precluding polyp identification.
结局指标
主要结局
Efficacy of Resection (Central Post-Resection Biopsies)
时间窗: 1 day
Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.
Efficacy of Resection (Peripheral Post-Resection Biopsies)
时间窗: 1 day
Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.
次要结局
- Polyp Resection Time(1 day)
- Resection Preparation Time(1 day)
- Total Procedure Time(1 day)
- Adverse Events(30 Days)
- Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm(At first surveillance colonoscopy, typically 6 months to 12 months)
研究者
John J. Guardiola
Assistant Professor of Clinical Medicine
Indiana University