Soft Coagulation for the Prevention of Adenoma Recurrence After Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multicentre, Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 455
- 试验地点
- 4
- 主要终点
- Endoscopic recurrence
研究概览
简要总结
Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) >= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.
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 (Participant)
盲法说明
Patients were blinded to the treatment allocation. The endoscopists performing the index and surveillance procedures were not blinded to the treatment.
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
- •Referred for removal of a colonic polyp >= 20mm in size
- •Able to give informed consent to involvement in trial
排除标准
- •Younger than 18 years of age
- •Highly dependant on medical care
- •Women who are pregnant or may be pregnant.
- •Taken clopidogrel within 7 days
- •Taken warfarin within 5 days
- •Had full therapeutic dose unfractionated heparin within 6 hours
- •Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
- •Known clotting disorder
- •Previous attempt at EMR of the polyp referred for resection
- •Polyp located at the ileo-caecal valve, appendiceal orifice
- •Fully circumferential polyp
- •Incomplete snare resection of the polyp
研究组 & 干预措施
No Coagulation Arm
Patients do not receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect
干预措施: No Snare Tip Soft Coagulation (Other)
Coagulation Arm
Patients to receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect
干预措施: Snare Tip Soft Coagulation (Other)
结局指标
主要结局
Endoscopic recurrence
时间窗: 4-6 months and 18 months
Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up
次要结局
- Perforation during EMR(During index procedure)
- Post EMR bleeding(Post Index procedure)
- Readmission(After index procedure)
- Histologic recurrence(4-6 months and 18 months)
- En bloc resection(Index procedure)
- Duration(Index procedure)
- Number of injections for hemostasis(Index procedure, if post EMR bleeding)
- Location of bleeding vessels(Index procedure, if post EMR bleeding)
- Delayed perforation(After index procedure)
- Snare resections(Index procedure)
- Size/number of bleeding vessels(Index procedure, if post EMR bleeding)
研究者
Professor Michael Bourke
Director of Gastrointestinal Endoscopy
Western Sydney Local Health District