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Prospective Study to Assess the Diagnostic Utility of Amyl Nitrite in Patients With Suspected Achalasia Undergoing High Resolution Esophageal Manometry (HREM) (Amyl Nitrite)

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ClinicalTrials.gov Identifier: NCT02428959
Recruitment Status : Recruiting
First Posted : April 29, 2015
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

This research is being done to see if a study drug called amyl nitrite can be helpful with diagnosing different disorders affecting the lower esophageal sphincter in patients with dysphagia (difficulty swallowing foods) undergoing high resolution esophageal manometry (HRM).

Dysphagia may be one of the symptoms of a condition known as idiopathic achalasia. Achalasia is a disorder of the esophagus, the tube that carries food from the mouth to the stomach. This affects the ability of the esophagus to move food toward the stomach. Pseudoachalasia is a secondary form of achalasia, which has very similar symptoms but is caused by different reasons. Because the treatments for achalasia and pseudoachalasia are different, it is important to correctly diagnose each condition. At this time, there is no way to distinguish the two with the current tests used at Johns Hopkins.

Amyl nitrite relaxes vascular smooth muscle and has been studied previously as a potential means to separate achalasia from pseudoachalasia. Amyl nitrite is approved by the Food and Drug Administration (FDA) for the treatment of cardiac angina. It is not approved for use in motility testing and its use in this study is considered investigational. Investigators hope that the results from the proposed study could have significant clinical implications for patient management by helping doctors distinguish between achalasia and pseudoachalasia and allow them to choose appropriate treatment.

Patients with dysphagia (difficulty swallowing foods) undergoing routinely scheduled high resolution esophageal manometry (HRM) may join this study.


Condition or disease Intervention/treatment Phase
Dysphagia Achalasia Drug: Amyl Nitrite Not Applicable

Detailed Description:

A single center, prospective study at a tertiary-care referral center (JHH). All patients will be provided with informed consent to undergo HRM with provocation as part of routine care to evaluate dysphagia symptoms or evaluation of known achalasia. All procedures will be performed as part of routine care and therefore no procedures will be performed for the purposes of research specifically.

Primary Objective: To determine the diagnostic advantage of the addition of the provocative amyl nitrite test in patients with dysphagia undergoing high resolution esophageal manometry (HRM)

Secondary Objective:

  1. Measure change of LES pressure after amyl nitrite inhalation in patients with dysphagia undergoing high resolution esophageal manometry (HRM)
  2. To assess the ability of amyl nitrite inhalation to differentiate achalasia from pseudoachalasia
  3. To assess the ability of amyl nitrite inhalation to differentiate partial fundoplication-related dysphagia versus that due to recrudescence of achalasia in patients who have undergone a prior myotomy.
  4. To assess the ability of amyl nitrite inhalation to differentiate post-fundoplication dysphagia from a newly diagnosed motility disorder in patients who have undergone a fundoplication for gastroesophageal reflux disease.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Study to Assess the Diagnostic Utility of Amyl Nitrite in Patients With Suspected Achalasia Undergoing High Resolution Esophageal Manometry (HREM)
Study Start Date : June 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Amyl Nitrite
Amyl nitrite is the chemical compound with the formula C5H11ONO. It relaxes vascular smooth muscle.The method of administration is via inhalation with onset of action within of 30 seconds and ends 2-3mins. In a study by Dodds et al., amyl nitrite is used as part of radiologic esophagram test in order to distinguish patients with pseudoachalasia from those with idiopathic achalasia since amyl nitrite has transient effect on the lower esophageal sphincter (LES). The study revealed that the LES pressure in achalasia patient decreases substantially in response to amyl nitrite with the measurable increase in LES diameter of 3 mm to an average of 4.6m. In contrast, amyl nitrite does not relax the LES segment in pseudoachalasia and has no change in LES diameter. Thus, the investigators anticipate amyl nitrite inhalation will be beneficial at the LES during HREM.
Drug: Amyl Nitrite
Amyl nitrite is the chemical compound with the formula C5H11ONO. It relaxes vascular smooth muscle; decreases venous ratios and arterial blood pressure; reduces left ventricular work; decreases myocardial oxygen consumption. The method of administration is via inhalation with onset of action within of 30 seconds and ends 2-3mins. In a study by Dodds et al., amyl nitrite is used as part of radiologic esophagram test in order to distinguish patients with pseudoachalasia from those with idiopathic achalasia since amyl nitrite has transient effect on the lower esophageal sphincter (LES). The study revealed that the LES pressure in achalasia patient decreases substantially in response to amyl nitrite with the measurable increase in LES diameter of 3 mm to an average of 4.6m. In contrast, amyl nitrite does not relax the LES segment in pseudoachalasia and has no change in LES diameter. Thus, the investigators anticipate amyl nitrite inhalation will be beneficial at the LES during HREM.




Primary Outcome Measures :
  1. Measure LES pressure after amyl nitrite inhalation in patients with dysphagia undergoing high resolution esophageal manometry (HRM) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Measure Blood Pressure and Heart Rate at baseline and after administration of amyl nitrite [ Time Frame: 1 month ]
  2. Number of Participants with Adverse Events with amyl nitrite inhalation [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-80 years old
  • symptoms of dysphagia or a known history of achalasia

Exclusion Criteria:

  • Patients with comorbidity and contraindications to use of amyl nitrite inhalation: Glaucoma, Recent head trauma or cerebral hemorrhage, Hypotension, Concurrent use of nitrite, Pregnancy, Aortic stenosis, Patients with increased intracranial pressure, Caution in patients with coronary artery disease, Pulmonary hypertension
  • Non-English speakers
  • Patients <18 years old
  • Those who lack capacity to give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428959


Contacts
Contact: John Clarke, MD 410-955-9696 john.clarke@jhu.edu
Contact: Alan Tieu, MD 410-955-9696 alan.tieu@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: John Clarke, MD    410-955-9696    john.clarke@jhu.edu   
Contact: Alan H Tieu, MD    410-955-9696    alan.tieu@jhmi.edu   
Principal Investigator: John Clarke, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Ellen Stein, MD Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02428959     History of Changes
Other Study ID Numbers: IRB00029912
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Keywords provided by Johns Hopkins University:
Amyl Nitrite
High Resolution Manometry

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Amyl Nitrite
Vasodilator Agents