Clinical Trial: Sensorimotor Dysfunction in Achalasia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Sensorimotor Dysfunction in Achalasia

Brief Summary: 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.

Detailed Summary:

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. F
Sponsor: Mayo Clinic

Current Primary Outcome: Presence of discomfort during barostat [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: symptoms (followup phone survey) [ Time Frame: 3, 6 months, 2, 4 years ]

Measuring symptoms (dysphagia, regurgitation, chest pain, nocturnal cough) with modified Eckardt Score 0 None 1 occasional 2 daily

None Occasional Daily



Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: April 6, 2015
Date Started: October 2016
Date Completion: August 2017
Last Updated: September 12, 2016
Last Verified: September 2016