Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Speed of endoscopic submucosal dissection
研究概览
简要总结
Peroral endoscopic esophagel myotomy (POEM) is a third space endoscopy technique that depends on creating a submucosal tunnel to expose the esophageal muscle and eventually perform an esophageal myotomy. Submucosal dissection can be performed using numerous electrosurgical modes. Spray coagulation has been anecdotally favored by many endoscopists due to its high coagulation power and assumed safety. Recently, Precisect mode has been developed, it has theoretical advantages of very minimal tissue penetration and minimal to no charring effect. In this trial, the investigators compare the efficacy and safety of both electrosurgical modes in POEM procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Allocation of patients will be in sealed envelopes to be opened on day of the procedure. The investigator and care provider (same) will thus be unmasked. Participant and outcomes assessor will remain masked until the end of the study.
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
- •Patients undergoing POEM procedure for any esophageal motility disorder
- •Esophageal motility disorder confirmed by high-resolution manometry and gastroscopy
排除标准
- •Esophageal varices
- •Esophageal neoplasms
- •Non-correctable coagulopathy
- •Failure to provide an informed consent
研究组 & 干预措施
Spray coag mode
After initial mucosal incision, Endoscopic submucosal dissection will be performed using Spray coag mode using ERBE VIO 3 generator (effect 3-3.5)
干预措施: endoscopic submucosal dissection using SPRAY COAG mode (Procedure)
Precisect mode
After initial mucosal incision, Endoscopic submucosal dissection will be performed using Precisect mode using ERBE VIO 3 generator (effect 4.5-5)
干预措施: endoscopic submucosal dissection using Precisect mode (Procedure)
结局指标
主要结局
Speed of endoscopic submucosal dissection
时间窗: during the procedure
Speed of dissection (cm/minute)
次要结局
- Intraprocedural Bleeding(during the procedure)
- Significant Intraprocedural bleeding(during the procedure)
- Other Adverse events(during the procedure)
- Total procedure duration(during the procedure)
- Endoscopic submucosal tunneling duration(during the procedure)