Clinical trial NCT02434991: Sensorimotor Dysfunction in Achalasia
Official title: Sensorimotor Dysfunction in Achalasia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Achalasia
Keywords: trouble swallowing
food sticking
Achalasia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of discomfort during barostat
timeFrame: 20 minutes
Secondary outcomes:
measure: symptoms (followup phone survey)
timeFrame: 3, 6 months, 2, 4 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Karthik Ravi, MD
role: PRINCIPAL_INVESTIGATOR
References: