A Phase 3 interventional study of Peroral endoscopic myotomy in Primary Achalasia, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-25.
Sponsored by Hospices Civils de Lyon · Phase 3, Interventional, and Treatment
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.
140 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 93 interventional studies indexed under Esophageal Achalasia.
Browse Esophageal Achalasia studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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Exclusion Criteria:
Peroral endoscopic myotomy
Procedure: Peroral endoscopic myotomy
An endoscopy is performed under anesthesia with orotracheal intubation. After submucosal saline injection, an entry point in the submucosal space is created at 10 cm above the cardia. The endoscope will create a 12cm long tunnel in the caudal direction by submucosal dissection, stopping at 2cm below cardia. Then the muscular circular internal layer is sectioned on a 9cm length, starting 3 cm below the submucosal entry point. At the end the submucosal entry point is closed with metallic clips. A scanner is performed after the procedure so as to check the esophageal wall integrity. Alimentation is progressively introduced at day 1. This is a study of a procedure - peroral endoscopic myotomy (POEM). No new, unapproved device is used. All endoscopic tools are already approved for endoscopic submucosal dissection and associated complications (hemorrhage or perforation): dissection knifes, hot biopsy forceps, endoscopic metallic clips.
Percentage of patients with clinically significant perforation
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)
Time frame: Day 1 after procedure
percentage of patients with Eckardt score less than 3
Eckardt score calculated at baseline and after procedure
Time frame: at 3rd and 12th month after procedure
significant variation of Eckardt score
Eckardt score calculated at baseline and after procedure
Time frame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure
significant variation of GIQLI score
GIQLI score calculated at baseline and after procedure
Time frame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure
significant variation of high resolution manometry parameters
high resolution manometry performed at baseline and at 3rd month after the procedure
Time frame: at baseline and at 3rd month after the procedure
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon