Sensorimotor Dysfunction in Achalasia



Status:Withdrawn
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 90
Updated:8/18/2018
Start Date:March 2018
End Date:August 14, 2018

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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.

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.

Inclusion Criteria:

- Adults ages 18-90

- Patients with achalasia, defined by an esophageal manometry study consistent with the
diagnosis

Exclusion Criteria:

- 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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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