Peroral Endoscopic Myotomy Versus Botulinum Toxin Injection in Spastic Esophageal Disorders
Esophageal Achalasia, Esophageal Spasm, Diffuse, Esophageal Motility Disorders
About this trial
This is an interventional treatment trial for Esophageal Achalasia focused on measuring spastic esophageal disorders, achalasia, diffuse esophageal spasm, hypercontractile (jackhammer) esophagus, Botulinum toxin injection, peroral endoscopic myotomy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Other
Other
Botulinum toxin injection
peroral endoscopic myotomy
Drug/Device: Botulinum toxin injection; Endoscopic Botulinum toxin (BTX) injection at lower esophagus; Upper endoscopy with Botulinum toxin injection. The procedure will be performed as an outpatient basis by an endoscopist. Sedation can be in form of conscious sedation, monitored anesthesia care or general anesthesia. An upper endoscope will be inserted into the patient's mouth and advanced into lower esophagus. Botulinum toxin (Botox@) 100 units 8-10 (25 units/mL) will be injected in 1-ml portion in each of four quadrants about 1 cm above the Z-line (the LES region). At 1 month follow-up, patients who do not response to the first botox injection (Eckardt score > 3) will receive the second botox injection. At 3-month follow-up, POEM will be offered as a rescue therapy to both non-responders (Eckardt score > 3 at 3-month follow-up after the procedure) and relapsers (Eckardt score ≤ 3 at 3-month follow-up but becomes > 3 during the follow-up)
Procedure/Surgery: peroral endoscopic myotomy. The procedure will be performed by an endoscopist (gastroenterologist or surgeon). General anesthesia will be started and upper endoscope will be inserted into the patient's mouth and advanced into the stomach. Endoscopic myotomy will be performed. Mucosal entry will then be closed using endoscopic clips or endoscopic suturing. All patients will recover from their procedures according to standard practice. They will remain nothing per oral (NPO) the night after the procedure and started on intravenous proton pump inhibitors. A gastrografin esophagram will be obtained the next day and if no evidence of leak, the diet will be advanced to a soft diet for two weeks. The patients will be evaluated by study coordinator/PI on a daily basis during their hospitalization.