Clinical Trial: Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia

Brief Summary: Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. These symptoms are primarily caused by incomplete relaxation of a frequently hypertensive lower esophageal sphincter (LES) and to some extent by a lack of peristalsis in the tubular esophagus. Unfortunately, no therapy returns normal esophageal function. Treatment is therefore directed at lowering the LES pressure, with the aim of reducing the functional obstruction to bolus transit at this site. Current treatments can be endoscopic or surgical. Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia in some centers. The investigators purpose was to further evaluate the efficacy and the feasibility of POEM for patients with achalasia in a prospective larger study.

Detailed Summary:

  1. Patients were eligible for enrollment in the study if they had 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.

Sponsor: Shanghai Zhongshan Hospital

Current Primary Outcome: 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 during follow-up, an expected average of 2 years. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 during follow-up, an expected average of 2 years. ]


Original Secondary Outcome: Same as current

Information By: Shanghai Zhongshan Hospital

Dates:
Date Received: July 12, 2012
Date Started: August 2010
Date Completion: December 2014
Last Updated: July 22, 2012
Last Verified: July 2012