Sensorimotor Dysfunction in Achalasia
Primary Purpose
Achalasia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Barostat
Sponsored by
About this trial
This is an interventional diagnostic trial for Achalasia focused on measuring trouble swallowing, food sticking, Achalasia
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Barostat
Arm Description
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
Outcomes
Primary Outcome Measures
Presence of discomfort during barostat
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.
Secondary Outcome Measures
symptoms (followup phone survey)
Measuring symptoms (dysphagia, regurgitation, chest pain, nocturnal cough) with modified Eckardt Score 0 None 1 occasional 2 daily
None Occasional Daily
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02434991
Brief Title
Sensorimotor Dysfunction in Achalasia
Official Title
Sensorimotor Dysfunction in Achalasia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
August 14, 2018 (Actual)
Study Completion Date
August 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
Keywords
trouble swallowing, food sticking, Achalasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Barostat
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Barostat
Other Intervention Name(s)
Sensorimotor dysfunction
Intervention Description
During this study, the investigators will ask you to fill out questionnaires about your swallowing, chest pain, and heartburn. The investigators hope the patient will answer all of the questions, but patients can skip any questions they do not want to answer. The questionnaires will take about 15 minutes to complete.
A urine pregnancy test for females of childbearing years.
Patients will be asked to fast overnight (nothing to eat or drink for 8 hours) prior to the barostat test.
At this point healthy controls have completed the study.
Patients with achalasia will then undergo treatment for achalasia at the discretion of the primary clinician managing their case.
Patients will be contacted to complete a phone survey 3 & 6 months and 2 & 4 years after treatment.
Primary Outcome Measure Information:
Title
Presence of discomfort during barostat
Description
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
symptoms (followup phone survey)
Description
Measuring symptoms (dysphagia, regurgitation, chest pain, nocturnal cough) with modified Eckardt Score 0 None 1 occasional 2 daily
None Occasional Daily
Time Frame
3, 6 months, 2, 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karthik Ravi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sensorimotor Dysfunction in Achalasia
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