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临床试验/NCT05272046
NCT05272046已完成不适用

Comparison of the Performance of Monopolar Current Cutting Knife and Bipolar RFA Knife in POEM (Per-Oral Endoscopic Myotomy)

Baylor College of Medicine6 个研究点 分布在 3 个国家目标入组 104 人开始时间: 2022年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
6
主要终点
Change in pain score

研究概览

简要总结

Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal muscular disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissecting the esophageal muscle sphincter. The procedure is typically completed using standard monopolar energy, which are effective, but can be associated with post-procedural pain. More importantly, frequent exchange of various instruments are required in order to cut the right layers and to stop bleeding. The Speedboat-RSD is FDA approved for dissection of various tissue within the gastrointestinal tract tract but only a few studies have evaluated its use in POEM. Currently, the investigators have been performing EGD with POEM procedures using Speedboat-RSD as a standard of care procedure. The investigators would like to compare the performance of the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife in POEM. The investigators hypothesize the bipolar knife will allow for efficient completion of the POEM procedure with less post procedural pain.

详细描述

Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal motility disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissection of the esophageal submucosa followed by cutting of the esophageal muscle. The procedure is typically completed using standard monopolar cutting knives, which are effective, but can be associated with inadvertent thermal injury and post-procedural pain due to dissemination of higher voltage. More importantly, frequent exchange of various instruments are required in order to inject within the submucosa and to coagulate bleeding vessels. The Speedboat-RSD has an integrated injection needle for submucosal injection and uses bipolar radiofrequency energy (BRF) and microwave energy to dissect tissue/coagulate vessels. In essence, injection, submucosal dissection, cutting, and coagulation can all occur with one knife (2). It is FDA approved for submucosal dissection (ESD) and myotomy within the gastrointestinal tract but only a few studies have evaluated its use in POEM (3). Currently, the investigators have been performing EGD with the POEM procedure using Speedboat-RSD as a standard of care procedure. The investigators would like to compare the performance of the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife in POEM. The investigators hypothesize the bipolar knife will allow for efficient completion of the POEM procedure with less post-procedural related pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Patient will not know which electrocautery tool will be used in their procedure.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 18 years of age
  • Able to sign consent - Planned POEM procedure for all indications

排除标准

  • Pregnant patients
  • Prisoners
  • Unable to sign consent

研究组 & 干预措施

Bipolar Electrocautery tool

Experimental

Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure.

干预措施: Speedboat (Bipolar electrocautery knife) (Device)

Monopolar Electrocautery tool

Active Comparator

Patients randomized into this group will receive the standard of care monopolar tool for their POEM procedure.

干预措施: Per-oral Endoscopic Myotomy (Procedure)

Bipolar Electrocautery tool

Experimental

Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure.

干预措施: Per-oral Endoscopic Myotomy (Procedure)

结局指标

主要结局

Change in pain score

时间窗: Pre-procedure, 1-hour post procedure, 8-10 hours post procedure, and 24 hours post procedure.

Use of a Visual Analog Scale (VAS) from 0-10 with "0" being no pain and "10" being the worse pain to assess overall pain following the POEM procedure up to 24 hours.

次要结局

  • Study knife removal during procedure(Day 1)
  • Total procedure time (minutes)(Day 1)
  • Hospital Length-of-stay(Up to 1 week)
  • Adverse events(1 month, 3 months, 6 months, and 12 months.)
  • Technical success rate of patients who completed POEM procedure with the bipolar knife.(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Salmaan Azam Jawaid, MD

Principal Investigator, Assistant Professor

Baylor College of Medicine

研究点 (6)

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