Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 686
- 试验地点
- 1
- 主要终点
- Delayed bleeding
研究概览
简要总结
The goal of this clinical trial is to compare adverse even rates after EMR for large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions, LSLs) when performing complete or no defect closure. It will also evaluate lesion recurrence after EMR for large colorectal LSLs.
The hypothesis is that performing complete defect closure following EMR of large colorectal LSLs will result in lower rates of adverse events compared to cases where no defect closure is performed.
For participants with planned EMR, endoscopists will perform EMRs as per standard of care and:
- prophylactic defect closure will either not be performed (control group), or will be performed (experimental group);
- then, patients will be called between 14 and 44 days after EMR to assess for possible adverse events, and electronic medical files will be verified for emergency room visits and healthcare received for an adverse event;
- finally, patients will undergo follow-up colonoscopy 6 months and 18 months after randomization.
详细描述
This trial is an open-label, two-arm, parallel-group, multicenter, randomized controlled superiority trial. Patients undergoing EMR will be randomized in a 1:1 ratio and assigned to undergo no closure (control group) vs complete defect closure (experimental group).
Participants with planned EMR procedures will be approached by a research assistant before the EMR to request study participation. To mitigate loss to follow-up, patients will be questioned on their preferred contact method with multiple contact methods obtained to adequately reach patients. The importance of follow-up after EMR to detect and treat recurrence will also be highlighted both verbally and in the consent forms during initial patient contact.
Despite being experienced, all endoscopist participants will review dedicated teaching videos showing the standardized EMR approach. Videos demonstrating key technical details defect closure will also be circulated across sites to ensure a standardized approach for both procedures as described in the literature.
- Control group: EMR will be performed as per standard of care with submucosal injection and electrocautery resection of all visually visible polyp tissue using a snare. After performing EMR with thermal ablation, prophylactic defect closure will not be performed. Endoscopists can chose to close defects if there are significant concerns for risk of perforation or active perforation after EMR. When the endoscopist determines that the resection is complete, a tattoo will be placed 3 cm distal to the resected lesion to allow for better identification of the resection site in case of follow-up colonoscopy for delayed bleeding. If multiple large polyps are found and removed, the largest lesion (study polyp) will be marked with two tattoos 3 cm distal and 3 cm proximal to the lesion, to clearly identify the study polyp resection site.
- Experimental group: EMR will be performed as per standard of care with submucosal injection and electrocautery resection of all visually visible polyp tissue using a snare.
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
- Single (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);
- •appendiceal orifice or terminal ileum invasion;
- •pregnancy.
研究组 & 干预措施
Endoscopic Mucosal Resection (EMR)
After performing EMR with thermal ablation, prophylactic defect closure will not be performed.
干预措施: No prophylactic defect closure (Procedure)
Endoscopic Mucosal Resection (EMR) + prophylactic defect closure (defect closure)
Prophylactic defect closure will be performed using at least one new generation closure device.
结局指标
主要结局
Delayed bleeding
时间窗: 14 days
Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention.
Delayed perforation
时间窗: 14 days
Defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract
次要结局
- Lesion recurrence(6 months)
- Clinically significant delayed bleeding in the distal colon(14 days)
- Any delayed bleeding(14 days)
- Clinically significant delayed bleeding in the proximal colon(14 days)
研究者
Daniel Von Renteln
Gastroenterologist, MD
Centre hospitalier de l'Université de Montréal (CHUM)