Prospective Randomized Controlled Trial Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AdventHealth
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Adenoma Reocurrance
研究概览
简要总结
Non-inferiority trial comparing the recurrence rate of adenomas in non-pedunculated colonic lesions following endoscopic mucosal resection with margin marking (EMR-MM) and endoscopic mucosal resection with thermal margin ablation (EMR-STSC)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Ability to provide informed consent
- •Patient scheduled to undergo colonoscopy for the evaluation and removal of colon polyps
- •Non-pedunculated polyps ≥ 20 mm size
排除标准
- •Pedunculated polyps
- •Inflammatory bowel disease
- •Inability to provide informed consent
- •Lesions < 20 mm in size (largest dimension)
- •Lesion involves the lips of the ileocecal valve, is located at the appendiceal orifice and/or is fully circumferential.
- •Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy
研究组 & 干预措施
EMR-MM
Mucosal markings are placed clearly outside the visible margin of the lesion (polyp) by placing superficial cautery marks with the tip of the endoscopic snare approximately 3 mm away from the polyp margin. Successful marking with diathermy is established by visual identification of white circular "dots" around the entire outer border of the lesion. EMR is then performed as per standard technique as described above.
EMR-STSC
Endoscopic mucosal resection with thermal margin ablation (STSC) will be performed of the entire margin of the mucosal defect, by using a light touch with 1 to 2 mm of the exposed snare tip aiming to create a 2 to 3 mm rim of completely ablated tissue around the entire circumference of the resection defect. Successful STSC is confirmed by the presence of a rim of whitening mucosa around the defect
结局指标
主要结局
Adenoma Reocurrance
时间窗: 3 - 12 (+/- 6 months)
During Screening Colonoscopy (SC) 1, between 3 -12 post initial procedure. The post-EMR site will be assessed and biopsied for histology to assess for recurrence of adenoma.
次要结局
- Incidence of overall severe adverse events: Postpolypectomy Syndrome(Index procedure, 1 - 3 days post, 30 days.)
- Comparison of MM vs STSC procedure time(Index procedure visit)
- Incidence of overall severe adverse events: Bleeding(Index procedure, 1 - 3 days post, 30 days.)
- EMR procedure time(During procedure visit)
- Incidence of overall severe adverse events: Perforation(Index procedure, 1 - 3 days post, 30 days.)