Skip to main content
OpenTrials
Completed

NCT Number: NCT01560559

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinique de Hépatogastroentérologie

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both sexes aged over 18 years old
  • Patients who have signed the informed consent form before any study related procedure
  • Primary achalasia of the cardia with Eckardt score > 3
  • Non sigmoid achalasia or S1 sigmoid type achalasia at barium meal Rx study
  • ASA score (American Society of Anaesthesiologists) 1 or 2
  • Patients affiliated to a social security health system

Exclusion criteria

  • Patients with age less than 18 years old
  • Patients without discernment with legal protection
  • Patients who will not be able to abide with study follow-up as judged by the investigator
  • Patients which cannot provide a written informed consent
  • Patient refusing to participate in the study, without informed consent
  • Pregnant or breastfeeding women, women in fertile age for procreation without efficient contraception, and/or positive serum βHCG test
  • Concomitant participation in other clinical trial
  • S2 sigmoid type primitive achalasia of the cardia
  • Pseudo-achalasia (esophageal carcinoma),
  • History of Barrett's esophagus with or without dysplasia, malignant tumors of the esophagus
  • History of esophageal strictures, systemic sclerosis
  • History of esophageal varices
  • History of endoscopic or surgical therapy of the esophageal achalasia
  • History of inferior endoscopic or surgical esophageal sphincter manipulation (sutures, polymers injection, adhesive bands)
  • History of surgical interventions of the esophagus or stomach (fundoplication, Heller-Dor myotomy, gastric resections, vagotomy with or without gastric drainage)
  • History of congenital of acquired coagulation anomalies: hemorrhagic diseases, hemostasis disturbances (TP < 60%, TCA > 40 seconds, platelets < 60000/mmc)
  • ASA score (American Society of Anaesthesiologists) 3, 4, 5 or 6
  • Cancer, liver, respiratory, renal or heart failure which put the patients in the ASA risk group 3,4,5 or 6.

Treatment and study plan

Peroral endoscopic myotomy

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: TAMEO

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 22, 2012
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.