Peroral Endoscopic Myotomy Versus Botulinum Toxin Injection in Spastic Esophageal Disorders

Spastic disorders of the esophagus encompass hyperactive conditions of the esophagus due to
either abnormal premature contractions or extreme vigor. In the current iteration of the
Chicago classification, spastic esophageal disorders include spastic (type III) achalasia,
diffuse esophageal spasm (DES), and hypercontractile (jackhammer) esophagus. Management of
these spastic esophageal disorders is challenging and not clearly defined. Several medical
therapies have been suggested and include acid suppression, nitrates, muscle relaxants, and
visceral analgesics. For those who fail to response to medical therapy, the treatment options
are limited.

Botulinum toxin (BTX) injection is an effective therapeutic option for spastic esophageal
disorders, however many patients experience symptoms relapse with this treatment requiring
repeated injections.

Heller myotomy is a surgical option for patients with esophageal spastic disorders. As
compared to other types of achalasia, the response rate to surgical myotomy was lower in
patient with spastic achalasia. The theoretical reason for this is that the disease involves
not only the lower esophageal sphincter (LES) but also the esophageal body. Given data to
suggest that surgical myotomy may be effective in treating patients with spastic esophageal
disorders, peroral endoscopic myotomy (POEM), which is a less invasive treatment modality,
has recently been studied for these difficult-to-treat patients. An initial study reported
high success rate of POEM for severe spastic esophageal disorders. The response rate as
defined by Eckardt score to ≤ 3 was 96% in spastic achalasia, 100% in DES and 70% in those
with Jackhammer esophagus after a median follow-up of 234 days in a largest case series of
medically refractory spastic esophageal disorders.

To date, the optimal treatment for patients with severe symptomatic esophageal spastic
disorders who fail medical therapy is unclear. Here, investigators aim to compare POEM and
BTX injection in a randomized design.

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

Inclusion Criteria:

1. Adult patients age 18 - 80 years old.

2. 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.

3. 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.

4. Overall symptoms score (Eckardt score) > 3

5. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Diagnosis of spastic esophageal disorder was not confirmed by HRM testing.

2. Previous surgery of the esophagus or stomach

3. Previous BTX injection at the esophagogastric junction (EGJ) or LES.

4. Active severe esophagitis

5. Large lower esophageal diverticula

6. Large > 3cm hiatal hernia

7. Megaesophagus (> 6 cm)

8. Sigmoid esophagus

9. Known gastroesophageal malignancy

10. Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability,
severe pulmonary disease or other contraindication to endoscopy

11. Cirrhosis with portal hypertension, varices, and/or ascites

12. 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.

13. Pregnant or breastfeeding women (all women of child-bearing age will undergo urine
pregnancy testing)