Reducing Neoplasia Recurrence After Endoscopic Resection of Large Colorectal Polyps
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 892
- 试验地点
- 2
- 主要终点
- Recurrence after colorectal EMR between the h-APC and STSC methods
研究概览
简要总结
Large (≥20mm) colorectal polyps often harbor areas of advanced neoplasia, making them immediate colorectal cancer (CRC) precursors. Such polyps have to be completely removed to prevent CRC and to avoid surgery and/or adjuvant therapy. The laterally spreading lesions (LSLs) are removed via endoscopic mucosal resection (EMR). However, recurrence is common. New techniques for LSL resection (hybrid argon plasma coagulation (h-APC) margin and base ablation) have shown a reduction in recurrence following the interventions.
We hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation during EMR of large (≥20mm) colorectal LSLs will lead to lower rates of lesion recurrence compared to Snare tip soft coagulation (STSC) margin ablation.
详细描述
This trial is an open-label, two-arm, parallel-group, multicenter, randomized controlled superiority trial. Patients undergoing EMR will be randomly assigned in a 1:1 ratio to undergo additional STSC margin ablation (control group and current standard of care) or h-APC ablation of the margins and base (experimental group).
Patients will be enrolled in the study before the endoscopy procedure, or in the outpatient clinic.
Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation regimen before their scheduled procedure.
EMR intervention will be performed for all eligible patients with a large laterally spreading lesions (LSLs) by expert endoscopists. Only if a polyp meets inclusion criteria, the study subject will be enrolled and randomized into one of these 2 groups:
- Group 1: EMR + h-APC margin and base thermal ablation
- Group 2: EMR + STSC of the margin
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
- Double (Participant, Outcomes Assessor)
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
- •adult ≥18 years old
- •patients undergoing EMR for a large (≥20mm) colorectal LSL
- •patients providing written and informed consent for study participation.
排除标准
- •inflammatory bowel disease;
- •non-elective colonoscopy;
- •poor general health (American Society of Anesthesiologists classification >III);
- •coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets <50 x 109/L);
- •pedunculated polyps (Paris class Ip, Isp);
- •overt signs of deep submucosal invasive cancer (JNET 3);
- •biopsy proven invasive carcinoma in a potential study polyp.
- •Pregnant women
结局指标
主要结局
Recurrence after colorectal EMR between the h-APC and STSC methods
时间窗: 4 years
Lesion recurrence at first follow-up after EMR of large (≥20mm) colorectal LSLs when performing STSC margin ablation or h-APC margin and base ablation. Defined by visual recurrence or pathology-confirmed hyperplastic, serrated or adenomatous histology of the same histology of the index lesion at the tattooed resection site on at least one of four random biopsies of resection scars. These will be evaluated from an intention to treat and per protocol standpoint.
次要结局
- Adverse event rates after EMR with STSC or h-APC(4 years)
- Technical success of STSC or h-APC(4 years)
- Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC(4 years)
- High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period.(4 years)
- CRC occurrence during the 18-month follow-up period(4 years)