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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
Clinique de Hépatogastroentérologie
Lyon, France
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.