Esophageal Achalasia Clinical Trial
Official title:
Peroral Endoscopic Remyotomy for Failed Heller Myotomy
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.
1. 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).
2. 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.
3. 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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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