Clinical Trial: Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

Brief Summary: Recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and Heller-Dor surgical myotomy. Endoscopic myotomy has been recently proposed in human patient in expert centers in Japan, US and Germany. In theory, endoscopic myotomy is as effective as surgical myotomy but less invasive and more effective with less complications than endoscopic pneumatic dilation. Up to now, published studies have confirmed these expectations, with 100% efficacy and no clinically significant complications. The present clinical trial with study the security and efficacy of peroral endoscopic myotomy in primary achalasia patients.

Detailed Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome: Percentage of patients with clinically significant perforation [ Time Frame: Day 1 after procedure ]

Clinically significant perforation is defined as an ensemble of procedural, clinical, biological and imaging parameters:

  • perforation seen during procedure with placement of endoscopic metallic clips as closing method
  • acute severe persistent pain, fever over 38.5°C, subcutaneous emphysema, pneumomediastinum, penumoperitoneum
  • elevated white blood count with elevated neutrophils and elevated CRP, ascending values
  • subcutaneous emphysema, pneumomediastinum, penumoperitoneum seen at imaging studies (day 1 CT scan)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • percentage of patients with Eckardt score less than 3 [ Time Frame: at 3rd and 12th month after procedure ]
    Eckardt score calculated at baseline and after procedure
  • significant variation of Eckardt score [ Time Frame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure ]
    Eckardt score calculated at baseline and after procedure
  • significant variation of GIQLI score [ Time Frame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure ]
    GIQLI score calculated at baseline and after procedure
  • significant variation of high resolution manometry parameters [ Time Frame: at baseline and at 3rd month after the procedure ]
    high resolution manometry performed at baseline and at 3rd month after the procedure


Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: March 6, 2012
Date Started: March 2012
Date Completion:
Last Updated: May 22, 2015
Last Verified: March 2012