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临床试验/NCT02434991
NCT02434991撤回不适用

Sensorimotor Dysfunction in Achalasia

Mayo Clinic1 个研究点 分布在 1 个国家开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
试验地点
1
主要终点
Presence of discomfort during barostat

研究概览

简要总结

This study is being done to assess the esophageal muscle (swallowing tube) in patients with and without achalasia to further understand and help direct the treatment for patients with achalasia.

详细描述

Achalasia is currently defined solely on the basis of esophageal manometry. However, this fails to assess sensory function which may relate more to symptoms such as chest pain and heartburn. To date, the importance of sensory dysfunction in achalasia is poorly understood. The investigators want to define the relationship between esophageal sensory and motor dysfunction and symptoms in achalasia.

Following standard diagnostic evaluation including esophagogastroduodenoscopy (EGD), barium esophagram, and esophageal manometry, symptoms will be assessed utilizing a standardized questionnaire. The subjects will then undergo transoral placement of an esophageal barostat. Following a standard protocol of esophageal distension, esophageal body compliance will be recorded with esophageal body pressure and volume. Mechanosensitivity will then be assessed utilizing a stepwise esophageal distension, with patients reporting symptoms utilizing a Likert scale. Patients will then undergo conventional achalasia treatment with either pneumatic dilation or Heller myotomy at the discretion of the treating gastroenterologist. Thereafter patients will be followed via a standardized phone survey at 3 months, 6 months, 2 years, and 4 years after treatment to assess symptoms and treatment response. Patients will have standard clinical follow ups, including barium esophagram, at 1 year, 3 years, and 5 years following treatment. Outcomes: From 100 new patients with achalasia seen yearly at Mayo, the investigators anticipate recruitment of 40 eligible patients over 12 months and 10 healthy volunteers. The correlation between mechanosensitivity and esophageal body compliance with symptoms such as dysphagia, chest pain, and heartburn will be measured in Types I, II and III achalasia. The association of these parameters with conventional manometrically defined achalasia subtypes will also be measured. Finally, the relationship between sensorimotor dysfunction in achalasia and therapeutic outcomes will be assessed with development of predictive models to assess symptomatic outcome by barostat measurements.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults ages 18-90
  • •Patients with achalasia, defined by an esophageal manometry study consistent with the diagnosis

排除标准

  • •Patients with EGD or esophagram findings suggestive of pseudoachalasia
  • •Previous history of pneumatic dilation, Heller myotomy, or botulinum toxin injection to the distal esophagus
  • •Esophageal diameter greater than 6 cm
  • •Previous history of upper gastrointestinal surgery
  • •Medical conditions such as severe heart or lung disease that preclude safe performance barostat
  • •Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

研究组 & 干预措施

Barostat

Experimental

The barostat (a thin tube, with a deflated balloon attached at the end) will be placed through your mouth down your esophagus (swallowing tube) to where your stomach and esophagus meet. The 10-cm long balloon will then be inflated with step by step pressure increases of 4mmHg for 30 seconds each to a maximum pressure of 50mmHg. The patient will rate discomfort during each step of inflation

干预措施: Barostat (Device)

结局指标

主要结局

Presence of discomfort during barostat

时间窗: 20 minutes

During each distention, patients would report presence of discomfort as: 0) none 1) sensation without discomfort 2) mild discomfort 3) moderate discomfort 4) pain. This scale has been utilized in previous studies assessing esophageal mechanosensitivity.

次要结局

  • symptoms (followup phone survey)(3, 6 months, 2, 4 years)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karthik Ravi, M.D.

Karthik Ravi, M.D.

Mayo Clinic

研究点 (1)

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