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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Peroral endoscopic myotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peroral endoscopic myotomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with clinically significant perforation | Clinically significant perforation is defined as an ensemble of procedural, clinical, biological and imaging parameters:
| Day 1 after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients with Eckardt score less than 3 | Eckardt score calculated at baseline and after procedure | at 3rd and 12th month after procedure |
| significant variation of Eckardt score | Eckardt score calculated at baseline and after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry PONCHON, Pr | Hospices Civiles de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de Hépatogastroentérologie | Lyon | 69003 | France |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| 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 | 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 | at baseline and at 3rd month after the procedure |
| D004066 | Digestive System Diseases |