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Peroral Endoscopic Myotomy for Primary Esophageal Achalasia (TAMEO)

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ClinicalTrials.gov Identifier: NCT01560559
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : May 25, 2015
Information provided by (Responsible Party):

March 6, 2012
March 22, 2012
May 25, 2015
March 2012
January 2015   (Final data collection date for primary outcome measure)
Percentage of patients with clinically significant perforation [ Time Frame: Day 1 after procedure ]

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)
Same as current
Complete list of historical versions of study NCT01560559 on ClinicalTrials.gov Archive Site
  • percentage of patients with Eckardt score less than 3 [ Time Frame: at 3rd and 12th month after procedure ]
    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 ]
    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 ]
    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 ]
    high resolution manometry performed at baseline and at 3rd month after the procedure
Same as current
Not Provided
Not Provided
Peroral Endoscopic Myotomy for Primary Esophageal Achalasia
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.
Not Provided
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Primary Achalasia
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.

Experimental: Single Arm
Peroral endoscopic myotomy
Intervention: Procedure: Peroral endoscopic myotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2015
January 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: Thierry PONCHON, Pr Hospices Civiles de Lyon
Hospices Civils de Lyon
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP