Peroral Endoscopic Myotomy for Primary Esophageal Achalasia (TAMEO)

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 Overview

• Status: Completed
• Conditions: Primary Achalasia
• Intervention / Treatment: Procedure: Peroral endoscopic myotomy

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Clinique de Hépatogastroentérologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Thierry PONCHON, Pr, Hospices Civiles de Lyon

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): May 25, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Primary esophageal achalasia; endoscopic myotomy; high resolution manometry
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: 2011.696