Clinical Trial: POEM vs. Pneumatic Dilation for Esophageal Achalasia

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

Official Title: Peroral Endoscopic Myotomy Versus Pneumatic Dilation for Esophageal Achalasia: a Prospective Randomized Controlled Trial

Brief Summary: The purpose of this study is to determine the efficacy and safety of peroral endoscopic myotomy (POEM) compared with pneumatic dilation in the treatment of esophageal achalasia.

Detailed Summary:

Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food.

Currently, treatment options mainly focus on relief of the symptoms by reducing the LES pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia. However, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM) combined with Dor's antireflux procedure has gained considerable interest. The LHM can sustain therapeutic effects for long-term in approximately 80% of patients.

Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically, POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction.

However, the long-term efficacy and safety of POEM were not determined, and there was no prospective study that compared the POEM with other conventional treatment. Therefore, we aim to determine the efficacy and safety of POEM, compared with the pneumatic dilation, in the treatment of esophageal achalasia.

Sponsor: Nanfang Hospital of Southern Medical University

Current Primary Outcome: Therapeutic success [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Procedure related complication [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ]
  Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak etc.
• Time of treatment failure [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ]
  Time of treatment failure is defined as when the Eckardt score of patients are more than 3
• Pressure at the lower esophageal sphincter [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ]
  The basal LES pressure and the swallow-induced LES relaxation will be monitored and measured at the end of expiration. After introduction and equilibration, basal pressure is monitored during at least 5 minutes. Swallow-induced relaxation of the sphincter is assessed by 5 ml wet swallows, at least 30 s apart.
• Quality of life [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ]
  Patients will complete the quality-of-life questionnaires (the Medical Outcomes Study 36-Item Short-Form Health Survey, SF-36) for assessing quality of life

Original Secondary Outcome: Same as current

Information By: Nanfang Hospital of Southern Medical University

Dates:
Date Received: January 5, 2013
Date Started: December 2011
Date Completion: December 2013
Last Updated: January 11, 2013
Last Verified: January 2013