Back to resultsPeroral Endoscopic Myotomy for Primary Esophageal Achalasia (TAMEO)
Primary Purpose
Primary Achalasia
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Peroral endoscopic myotomy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Achalasia focused on measuring Primary esophageal achalasia, endoscopic myotomy, high resolution manometry
Eligibility Criteria
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.
Sites / Locations
- Clinique de Hépatogastroentérologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Peroral endoscopic myotomy
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
percentage of patients with Eckardt score less than 3
Eckardt score calculated at baseline and after procedure
significant variation of Eckardt score
Eckardt score calculated at baseline and after procedure
significant variation of GIQLI score
GIQLI score calculated at baseline and after procedure
significant variation of high resolution manometry parameters
high resolution manometry performed at baseline and at 3rd month after the procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01560559
Brief Title
Peroral Endoscopic Myotomy for Primary Esophageal Achalasia
Acronym
TAMEO
Official Title
Peroral Endoscopic Myotomy for Primary Esophageal Achalasia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Achalasia
Keywords
Primary esophageal achalasia, endoscopic myotomy, high resolution manometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Peroral endoscopic myotomy
Intervention Type
Procedure
Intervention Name(s)
Peroral endoscopic myotomy
Intervention Description
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 Outcome Measure Information:
Title
Percentage of patients with clinically significant perforation
Description
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)
Time Frame
Day 1 after procedure
Secondary Outcome Measure Information:
Title
percentage of patients with Eckardt score less than 3
Description
Eckardt score calculated at baseline and after procedure
Time Frame
at 3rd and 12th month after procedure
Title
significant variation of Eckardt score
Description
Eckardt score calculated at baseline and after procedure
Time Frame
at baseline and at 1st, 3rd, 6th and 12th month after the procedure
Title
significant variation of GIQLI score
Description
GIQLI score calculated at baseline and after procedure
Time Frame
at baseline and at 1st, 3rd, 6th and 12th month after the procedure
Title
significant variation of high resolution manometry parameters
Description
high resolution manometry performed at baseline and at 3rd month after the procedure
Time Frame
at baseline and at 3rd month after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry PONCHON, Pr
Organizational Affiliation
Hospices Civiles de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de Hépatogastroentérologie
City
Lyon
ZIP/Postal Code
69003
Country
France
12. IPD Sharing Statement
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Peroral Endoscopic Myotomy for Primary Esophageal Achalasia
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