跳至主要内容
临床试验/NCT04065516
NCT04065516Enrolling By Invitation不适用

Safety and Efficacy of Antireflux Ablation Therapy (ARAT) at Esophagogastric Junction in Patients With Reflux Disease After Peroral Endoscopic Myotomy (POEM) in Achalasia

Coordinación de Investigación en Salud, Mexico2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
44
试验地点
2
主要终点
A change in clinical symptoms of reflux disease assessed with a gastroesophageal reflux questionnaire after ARAT

研究概览

简要总结

The peroral endoscopic myotomy for the treatment of achalasia is associated with a higher incidence of gastroesophageal reflux disease compared with Heller's myotomy. Remodeling of the esophagogastric junction with hybrid argon plasma could decrease the passage of gastric or gastroduodenal content into the esophagus.

详细描述

Achalasia is the inability of the lower esophageal sphincter to relax in the context of dysfunction of esophageal peristalsis. Peroral endoscopic myotomy for the treatment of achalasia has an efficacy above 90%, being comparable with Heller's myotomy. The treatment of achalasia by peroral endoscopic myotomy is associated with a higher incidence of gastroesophageal reflux disease, compared with alternative therapies such as Heller's myotomy or pneumatic dilatation. Hybrid argon plasma at the level of the esophagogastric junction could generate remodeling of this region generating a partial stenosis and thereby decrease the passage of gastric or gastroduodenal content into the esophagus.

A clinical trial will be carried out, including all patients with achalasia, treated by peroral myotomy older than 18 years old, with abnormal acid exposure in the pHmetry test 3 months or more after treatment, who accept the management of ablation with hybrid argon plasma. To whom the ablation will be performed with Hybrid Argon Plasma and its effectiveness will be evaluated by clinical questionnaires, endoscopy and pHmetry measurement at the beginning, 3 months, 6 months and 12 months after the procedure.

Demographic and clinical data will be recorded in a data collection sheet, detailing the reflux questionnaire(GERDQ), Eckardt score, endoscopic findings of esophagitis according to Los Angeles classification and abnormal acid exposure in each evaluation. The data will be condensed into a database for subsequent statistical analysis and publication of results.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Achalasia type I, II, III
  • Treatment with POEM (Peroral Endoscopic Myotomy)
  • Abnormal acid exposure (>6%) in the 24h-pHmetry test more than three months after the procedure
  • Signed informed consent

排除标准

  • Patients who do not accept the treatment
  • Previous antireflux surgery
  • Previous Heller's Myotomy
  • Hiatal hernia greater than 3 centimeters
  • Hill's Classification Grade IV
  • Pregnancy
  • Patients with any contraindication for an endoscopy
  • Patients with esophageal or gastric varices

结局指标

主要结局

A change in clinical symptoms of reflux disease assessed with a gastroesophageal reflux questionnaire after ARAT

时间窗: measures will be performed at 3,6 and 12 months after ARAT

The clinical evaluation of reflux disease is going to be assessed by the use of a clinical gastroesophageal reflux disease questionnaire (GERD-Q) after ARAT. Reflux disease was considered positive when \>4 points is observed

A change in esophageal acid exposure assessed by pHmetry study after ARAT

时间窗: measures will be performed at 3,6 and 12 months after ARAT

A 24-hours pHmetry study is going to be used to measure esophageal acid exposure in esophagus after ARAT. DeMeester Score and the percentage of esophagic acid exposure will be used to assess pathologic reflux (\>14.73 and \> 6%, respectively)

A change in erosive esophagitis grade assessed by upper endoscopy after ARAT

时间窗: measures will be performed at 3,6 and 12 months after ARAT

Upper endoscopy is going to be used to measure the erosive esophagitis grade using the Los Angeles Esophagitis scale(grade A=mild, Grade B=moderate, Grade C=moderate high and Grade D=severe) after after ARAT

次要结局

未报告次要终点

研究者

发起方
Coordinación de Investigación en Salud, Mexico
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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