Diagnostic Utility of Amyl Nitrite in Patients With Suspected Achalasia Undergoing High Resolution Esophageal Manometry (HREM)

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alan H. Tieu, MD; Johns Hopkins University
• Collaborator: Johns Hopkins University
• Treatments: Amyl Nitrite

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