Primary Achalasia Clinical Trial
— TAMEOOfficial title:
Peroral Endoscopic Myotomy for Primary Esophageal Achalasia
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patients of both sexes aged over 18 years old 2. Patients who have signed the informed consent form before any study related procedure 3. Primary achalasia of the cardia with Eckardt score > 3 4. Non sigmoid achalasia or S1 sigmoid type achalasia at barium meal Rx study 5. ASA score (American Society of Anaesthesiologists) 1 or 2 6. Patients affiliated to a social security health system Exclusion Criteria: 1. Patients with age less than 18 years old 2. Patients without discernment with legal protection 3. Patients who will not be able to abide with study follow-up as judged by the investigator 4. Patients which cannot provide a written informed consent 5. Patient refusing to participate in the study, without informed consent 6. Pregnant or breastfeeding women, women in fertile age for procreation without efficient contraception, and/or positive serum ßHCG test 7. Concomitant participation in other clinical trial 8. S2 sigmoid type primitive achalasia of the cardia 9. Pseudo-achalasia (esophageal carcinoma), 10. History of Barrett's esophagus with or without dysplasia, malignant tumors of the esophagus 11. History of esophageal strictures, systemic sclerosis 12. History of esophageal varices 13. History of endoscopic or surgical therapy of the esophageal achalasia 14. History of inferior endoscopic or surgical esophageal sphincter manipulation (sutures, polymers injection, adhesive bands) 15. History of surgical interventions of the esophagus or stomach (fundoplication, Heller-Dor myotomy, gastric resections, vagotomy with or without gastric drainage) 16. History of congenital of acquired coagulation anomalies: hemorrhagic diseases, hemostasis disturbances (TP < 60%, TCA > 40 seconds, platelets < 60000/mmc) 17. ASA score (American Society of Anaesthesiologists) 3, 4, 5 or 6 18. Cancer, liver, respiratory, renal or heart failure which put the patients in the ASA risk group 3,4,5 or 6. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Clinique de Hépatogastroentérologie | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) |
Day 1 after procedure | Yes |
| Secondary | percentage of patients with Eckardt score less than 3 | Eckardt score calculated at baseline and after procedure | at 3rd and 12th month after procedure | No |
| Secondary | significant variation of Eckardt score | Eckardt score calculated at baseline and after procedure | at baseline and at 1st, 3rd, 6th and 12th month after the procedure | No |
| Secondary | 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 | No |
| Secondary | 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 | No |