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

NCT02428959 | Withdrawn DMC

• 1 other identifier: IRB00029912
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Achalasia

Keywords

Amyl Nitrite; High Resolution Manometry

Outcome Measures

Primary Outcomes (1)

• Measure LES pressure after amyl nitrite inhalation in patients with dysphagia undergoing high resolution esophageal manometry (HRM)

  3 months

Secondary Outcomes (2)

• Measure Blood Pressure and Heart Rate at baseline and after administration of amyl nitrite

  1 month

• Number of Participants with Adverse Events with amyl nitrite inhalation

  1 month

Study Arms (1)

Amyl Nitrite

EXPERIMENTAL

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

Interventions

Amyl Nitrite DRUG

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.

Amyl Nitrite

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Esophageal Achalasia

Interventions

Amyl Nitrite

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders

Intervention Hierarchy (Ancestors)

Nitrites; Organic Chemicals

Study Officials

• Ellen Stein, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 29, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

US (1)