Peroral Endoscopic Myotomy Versus Botulinum Toxin Injection in Spastic Esophageal Disorders

Withdrawn before enrolling · Not applicable

Conditions studied: Esophageal Achalasia, Esophageal Spasm, Diffuse, Esophageal Motility Disorders

In brief

To compare the efficacy of peroral endoscopic myotomy and Botulinum toxin injection in spastic esophageal disorders.

Key facts

Study ID

NCT02663206

Run by

Johns Hopkins University

People needed

0

Starts

2016-09-01

Expected to finish

2020-07-01

Last updated by the study team

2018-01-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients age 18 - 80 years old.
• Spastic disorders of the esophagus include spastic (type III) achalasia, distal esophageal spasm (DES), and hypercontractile (jackhammer) esophagus via high resolution esophageal manometry (HRM) 2.
• DES is characterized by normal esophagogastric junction relaxation (integrated relaxation pressure [IRP] <15 mm Hg) and ≥ 20% premature contractions.
• Spastic achalasia is defined as impaired EGJ relaxation (IRP ≥15 mm Hg) associated with ≥ 20% premature contractions.
• The diagnosis of jackhammer esophagus is defined as at least 1 swallow with a distal contractile integral (DCI) greater than 8000 mm Hg- s- cm.
• At least 6 months of symptoms (chest pain, dysphagia, regurgitation and/or weight loss) with no adequate response or intolerance to medical therapy including nitrates and/or calcium channel blockers.
• Overall symptoms score (Eckardt score) > 3
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Diagnosis of spastic esophageal disorder was not confirmed by HRM testing.
• Previous surgery of the esophagus or stomach
• Previous BTX injection at the esophagogastric junction (EGJ) or LES.
• Active severe esophagitis
• Large lower esophageal diverticula
• Large > 3cm hiatal hernia
• Megaesophagus (> 6 cm)
• Sigmoid esophagus
• Known gastroesophageal malignancy
• Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
• Cirrhosis with portal hypertension, varices, and/or ascites
• Uncorrectable coagulopathy defined by prothrombin time < 50% of control; partial thromboplastin time (PTT) > 50 sec, or international normalized ratio (INR) > 1.5), on chronic anticoagulation, or platelet count <75,000.
• Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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