Sensorimotor Dysfunction in Achalasia

NCT ID: NCT02434991

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2018-08-14

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.

Conditions

Achalasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Barostat

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

Group Type: EXPERIMENTAL

Barostat

Intervention Type: DEVICE

• 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.

Interventions

Barostat

• 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.

Intervention Type: DEVICE

Other Intervention Names

Sensorimotor dysfunction

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Karthik Ravi, M.D.

Karthik Ravi, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karthik Ravi, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

14-009073

Identifier Type: -

Identifier Source: org_study_id