Primary AchalasiaPhase 3TAMEONCT01560559
Peroral Endoscopic Myotomy for Primary Esophageal Achalasia
A Phase 3 study testing Peroral endoscopic myotomy in people with Primary Achalasia, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Achalasia
- What is being tested?
- Peroral endoscopic myotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Primary Achalasia
- Being tested
- Peroral endoscopic myotomy
- Keywords
- Primary esophageal achalasia, endoscopic myotomy, high resolution manometry
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroral endoscopic myotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Peroral endoscopic myotomy Receives: Procedure: Peroral endoscopic myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1 after procedure
Secondary outcomes (4)
percentage of patients with Eckardt score less than 3
Eckardt score calculated at baseline and after procedure
Measured: at 3rd and 12th month after procedure
significant variation of Eckardt score
Eckardt score calculated at baseline and after procedure
Measured: 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
Measured: 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
Measured: at baseline and at 3rd month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AchalasiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry PONCHON, Pr, Principal investigator, Hospices Civiles de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560559
- Sponsor's protocol ID
- 2011.696
- Acronym
- TAMEO
- Status last verified
- Mar 2012
- First submitted
- 6 Mar 2012
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroral Endoscopic Myotomy for Primary Esophageal Achalasia
- ClinicalTrials.gov ID
- NCT01560559
- Acronym / sponsor ID
- TAMEO / 2011.696
- Conditions
- Primary Achalasia
- Keywords
- Primary esophageal achalasia, endoscopic myotomy, high resolution manometry
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Procedure: Peroral endoscopic myotomyPeroral endoscopic myotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peroral endoscopic myotomyAn 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. | Procedure or surgery | Single Arm |
Primary outcome
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)
4 secondary outcomes
percentage of patients with Eckardt score less than 3
Time frame: at 3rd and 12th month after procedure
significant variation of Eckardt score
Time frame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure
significant variation of GIQLI score
Time frame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure
significant variation of high resolution manometry parameters
Time frame: at baseline and at 3rd month after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry PONCHON, Pr principal investigator
Hospices Civiles de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peroral endoscopic myotomy in people with Primary Achalasia, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with clinically significant perforation (time frame: Day 1 after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2015.