An interventional study of POEM in Esophageal Achalasia, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-07-11.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment
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.
140 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 93 interventional studies indexed under Esophageal Achalasia.
Browse Esophageal Achalasia studies →Shanghai Zhongshan Hospital is the lead sponsor of 638 studies on the registry; 285 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia.
Therapeutic success (a reduction in the Eckardt score to ≤3)
Time frame: Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.
Procedure-related adverse events
Time frame: All patients were scheduled for a follow-up visit at 1 month after POEM for EGD.
Lower esophageal sphincter (LES) pressure on manometry
Time frame: 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
Time frame: Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.
This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Zhongshan Hospital