Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

NCT ID: NCT01560559

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-01-31

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.

Conditions

Primary Achalasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Peroral endoscopic myotomy

Group Type: EXPERIMENTAL

Peroral endoscopic myotomy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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 βHCG 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry PONCHON, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civiles de Lyon

Locations

Clinique de Hépatogastroentérologie

Lyon, , France

Countries

France

Other Identifiers

2011.696

Identifier Type: -

Identifier Source: org_study_id