Peroral Endoscopic Myotomy for Primary Esophageal Achalasia (TAMEO)

This study is currently recruiting participants.
Verified March 2012 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01560559
First received: March 6, 2012
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Primary Achalasia
Procedure: Peroral endoscopic myotomy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Percentage of patients with clinically significant perforation [ Time Frame: Day 1 after procedure ] [ Designated as safety issue: Yes ]

    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)


Secondary Outcome Measures:
  • percentage of patients with Eckardt score less than 3 [ Time Frame: at 3rd and 12th month after procedure ] [ Designated as safety issue: No ]
    Eckardt score calculated at baseline and after procedure

  • significant variation of Eckardt score [ Time Frame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure ] [ Designated as safety issue: No ]
    Eckardt score calculated at baseline and after procedure

  • significant variation of GIQLI score [ Time Frame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure ] [ Designated as safety issue: No ]
    GIQLI score calculated at baseline and after procedure

  • significant variation of high resolution manometry parameters [ Time Frame: at baseline and at 3rd month after the procedure ] [ Designated as safety issue: No ]
    high resolution manometry performed at baseline and at 3rd month after the procedure


Estimated Enrollment: 16
Study Start Date: March 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560559

Contacts
Contact: Thierry PONCHON, Pr +33472110146 thierry.ponchon@chu-lyon.fr
Contact: Mihai CIOCÎRLAN, Dr +33472110146 ciocirlanm@yahoo.com

Locations
France
Clinique de Hépatogastroentérologie Recruiting
Lyon, France, 69003
Contact: Thierry PONCHON, Pr    +33472110146    thierry.ponchon@chu-lyon.fr   
Contact: Mihai CIOCÎRLAN, Dr    +33472110146    ciocirlanm@yahoo.com   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Thierry PONCHON, Pr Hospices Civiles de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01560559     History of Changes
Other Study ID Numbers: 2011.696
Study First Received: March 6, 2012
Last Updated: March 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Primary esophageal achalasia
endoscopic myotomy
high resolution manometry

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014