Peroral Endoscopic Remyotomy for Failed Heller Myotomy

Study Overview
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Brief Summary
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Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. With respect to long-term efficacy, Heller myotomy (HM) using an open or a laparoscopic approach has gained wide acceptance as the procedure of choice for the management of patients with primary achalasia in recent years. Although good or excellent long-term symptomatic response rates can be achieved in more than 90% of patients undergoing HM, recurrence or persistence of symptoms occurs in approximately 20%. Controversy exists regarding the therapy of patients with failed success after HM. Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia. Our purpose was to evaluate the efficacy and the feasibility of POEM for patients with failed HM.

Detailed Description
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Patients were eligible for enrollment in the study if they were age greater than 18 years and had recurrence/persistence of symptoms after primary HM with an Eckardt symptom score ≥ 4. The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy (EGD)). Exclusion criteria were severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk, pseudoachalasia, and megaesophagus (diameter of > 7 cm). All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry. Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires. The primary outcome of the study was therapeutic success (a reduction in the Eckardt score to ≤3) at the follow-up assessment. The secondary outcomes included procedure-related adverse events, LES pressure on manometry pre- and post POEM, reflux symptoms and medication use before and after POEM, and procedure-related parameters such as procedure time, hospital stay, and myotomy length.

Official Title
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Peroral Endoscopic Remyotomy for Failed Heller Myotomy

Conditions
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Esophageal Achalasia

Intervention / Treatment
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* Procedure: POEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years Recurrence/persistence of symptoms after primary HM with an Eckardt symptom score ≥ 4 The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy) Exclusion Criteria: Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk Pseudoachalasia megaesophagus (diameter of > 7 cm)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Failed HM<br>Patients were eligible for enrollment in the study if they were age greater than 18 years and had recurrence/persistence of symptoms after primary HM with an Eckardt symptom score ≥ 4. | Procedure: POEM<br>* Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic success (a reduction in the Eckardt score to ≤3) |  | Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related adverse events |  | All patients were scheduled for a follow-up visit at 1 month after POEM for EGD. | 
| Lower esophageal sphincter (LES) pressure on manometry |  | All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry | 
| Reflux symptoms and medication use before and after POEM |  | Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peroral endoscopic myotomy, Heller myotomy, persistent/recurrent achalasia.