Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- esophageal clearance
研究概览
简要总结
Outcome after treatment of achalasia is usually assessed by the Eckardt score (ES). The timed barium esophagogram (TBE) is used to objectively assess esophageal clearance after treatment. High-resolution manometry with impedancemetry (HRiM) provides information on esophageal clearance of liquids in addition to motility parameters. The aim of this study was to compare esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM.
详细描述
Consecutive patients treated with POEM had pre and post-POEM assessment with ES, TBE, and HRiM. Treatment failure was defined by an ES > 3 at 3 months post-POEM. Incomplete esophageal clearance (IEC) was defined by the presence of an esophageal stasis > 2 cm at 5 minutes in HRiM and/or TBE. The Eckardt score is evaluated at one year to estimate the prognostic value of measurements of esophageal clearance after treatment on long-term symptoms. The evaluation of the Eckardt score will be compared to the quality of life score. All of these examinations are carried out as part of routine care.
The supposed superiority of HRiM in the evaluation of esophageal clearance, systematically carried out in the assessment of Achalasia, could lead to no longer using TBE which is a irradiating examination for the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •The patients included are all patients treated by POEM at Bordeaux University Hospital between October 2020 and September 2024.
排除标准
- •Primary POEM failure, lost to follow-up, absence of completion of the ES, TBE or HRiM pre or post poem at 3 months.
结局指标
主要结局
esophageal clearance
时间窗: 3 months
Difference of esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM at 3 months
次要结局
- Quality of life : ASQ (Achalasia Quality of Life)(3 months)
- Quality of life : QLQ-OES24(3 months)
- Efficacy : score of Eckardt(3 months, 12 months)
- Quality of life : Score QLQ-SF36(3 months)
- Efficacy : esophageal clearance(3 months)
- Quality of life : GERD-HRQL(3 months)
- Quality of life : RDQ (Reflux Disease Questionnaire):(3 months)