AchalasiaPOEMNCT01692106
A Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia
A study testing Procedure: Per Oral Endoscopic Myotomy (POEM) in people with Achalasia, run by McMaster University at 1 site in Canada.
Trial summary
This study evaluates the feasibility of endoscopic myotomy for achalasia. In achalasia, there is loss of relaxation of the lower esophageal sphincter (LES), as well as a higher baseline pressure in the LES. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Achalasia
- What is being tested?
- Procedure: Per Oral Endoscopic Myotomy (POEM)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Dec 2014
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for a Heller myotomy
- No contra-indication to general anesthesia
- Their age is ≥18 years and ≤80 years
- Able to give written consent
Who cannot join
- Previous intervention for achalasia: any of previous Heller myotomy, Botox injections, endoscopic myotomy
- Previous mediastinal surgery
- Any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow or hiatal hernia > 2cm.
- Body mass index (BMI) > 40
- Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia.
This study evaluates the feasibility of endoscopic myotomy for achalasia. In achalasia, there is loss of relaxation of the lower esophageal sphincter (LES), as well as a higher baseline pressure in the LES. The most widespread treatment for this disease and the one that has the best long term results involves cutting the muscle layers of the lower esophagus and on the neighbouring stomach without injurying the underlying mucosa or inner layer of the esophageal wall. This is done during a surgery through the abdomen either with a big incision or more recently with the keyhole technique. This surgery has various potential complications, one of which being making a hole through the mucosa or not extending the cut on the muscle long enough to obtain adequate relaxation of the sphincter. The per oral endoscopic myotomy (POEM) is a new intervention that is done also under general anesthesia in the operating room; however, it involves no skin incisions and all the procedure is done through a fiber optic camera. It involves making a cut in the inner layer of the esophagus and then with cautery cut the muscle fibers responsible of the blockage and finally closing the initial opening with clips. In this study we will investigate the feasibility of this intervention both from a technical aspect as well as a logistical perspective given the local operating room constraints.
Read the detailed description
All patients will have routine pre-operative EGD, manometry, barium swallow, ph-metry. Equally all patients will undergo Eckardt's and grading systems of symptom severity before and after the intervention. The patients will have a gastro-graffin swallow in the first day after the surgery.
Procedure: Under general anesthesia upper endoscopy is performed using a standard single channel gastroscope. Submucosal injection with 10 ml saline with 1% methylen blue at the level of the mid esophagus is initially performed. A small longitudinal submucosal incision is created using a standard needle knife. For a sufficient entry point as well as submucosal tunnel, a dilating balloon is inserted submucosally via the created incision similar to the technique used in standard endoscopic submucosal dissection. The balloon is slightly inflated to allow sufficient entrance of the endoscope. The gastroscope is advanced into the submucosal space and the tunnel is created via needle knife or blunt dissection as appropriate. The tunnel is created distally and is stopped several centimeters beyond the lower esophageal sphincter (LES), which can easily be identified. Using flexible scissors, a triangle tip- or respectively an isolated tip-knife the clearly visible circular muscles are divided starting 4 cm above the LES extending 2 cm beyond the previously identified esophageal border. The longitudinal and serosal layers are left intact. Finally the mucosal entry is closed with standard endoscopic clips. Patients will receive standard postoperative care for surgical myotomy, including long-term follow-up.
If for any reason the endoscopic treatment is unable to be completed or infeasible, a standard laparoscopic treatment will be performed.
- Conditions
- Achalasia
- Being tested
- Procedure: Per Oral Endoscopic Myotomy (POEM)
- Keywords
- Heller myotomy
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Per Oral Endoscopic Myotomy (POEM)Procedure or surgery
lower esophageal sphincter muscle is sectioned through an unique endoscopic approach.
| Study group | Role | What they receive |
|---|---|---|
| peroral endoscopic myotomy (POEM) | Experimental | The Procedure: per oral endoscopic myotomy (POEM)will be performed on all patients in this single arm study. Receives: Procedure: Procedure: Per Oral Endoscopic Myotomy (POEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of the POEM procedure in achalasia
Patients will be consecutively evaluated on effectiveness of the endoluminal procedure by conducting standard diagnostics including postoperative gastrografin swallow. After 6 months standard esophagogastroduodenoscopy (EGD), high-resolution manometry and pH impedance will be done and a Quality of Life questionnaire will be filled out. Results will be compared to historical data of 40 conventional laparoscopic Heller myotomies.
Measured: 1-6 months
Secondary outcomes (1)
complications
post-operative complications, intra-operative outcomes as well as the Eckardt's grading systems of symptom severity and reflux grading secondary to achalasia.
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Hong MD, McMaster University
- Investigators
- Dennis Hong, MD, Principal investigator, St. Josephs' Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692106
- Acronym
- POEM
- Status last verified
- Sep 2015
- First submitted
- 19 Sep 2012
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia.
- ClinicalTrials.gov ID
- NCT01692106
- Acronym / sponsor ID
- POEM
- Conditions
- Achalasia
- Keywords
- Heller myotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Sep 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.
This study evaluates the feasibility of endoscopic myotomy for achalasia. In achalasia, there is loss of relaxation of the lower esophageal sphincter (LES), as well as a higher baseline pressure in the LES. The most widespread treatment for this disease and the one that has the best long term results involves cutting the muscle layers of the lower esophagus and on the neighbouring stomach without injurying the underlying mucosa or inner layer of the esophageal wall. This is done during a surgery through the abdomen either with a big incision or more recently with the keyhole technique. This surgery has various potential complications, one of which being making a hole through the mucosa or not extending the cut on the muscle long enough to obtain adequate relaxation of the sphincter. The per oral endoscopic myotomy (POEM) is a new intervention that is done also under general anesthesia in the operating room; however, it involves no skin incisions and all the procedure is done through a fiber optic camera. It involves making a cut in the inner layer of the esophagus and then with cautery cut the muscle fibers responsible of the blockage and finally closing the initial opening with clips. In this study we will investigate the feasibility of this intervention both from a technical aspect as well as a logistical perspective given the local operating room constraints.
Detailed description
All patients will have routine pre-operative EGD, manometry, barium swallow, ph-metry. Equally all patients will undergo Eckardt's and grading systems of symptom severity before and after the intervention. The patients will have a gastro-graffin swallow in the first day after the surgery.
Procedure: Under general anesthesia upper endoscopy is performed using a standard single channel gastroscope. Submucosal injection with 10 ml saline with 1% methylen blue at the level of the mid esophagus is initially performed. A small longitudinal submucosal incision is created using a standard needle knife. For a sufficient entry point as well as submucosal tunnel, a dilating balloon is inserted submucosally via the created incision similar to the technique used in standard endoscopic submucosal dissection. The balloon is slightly inflated to allow sufficient entrance of the endoscope. The gastroscope is advanced into the submucosal space and the tunnel is created via needle knife or blunt dissection as appropriate. The tunnel is created distally and is stopped several centimeters beyond the lower esophageal sphincter (LES), which can easily be identified. Using flexible scissors, a triangle tip- or respectively an isolated tip-knife the clearly visible circular muscles are divided starting 4 cm above the LES extending 2 cm beyond the previously identified esophageal border. The longitudinal and serosal layers are left intact. Finally the mucosal entry is closed with standard endoscopic clips. Patients will receive standard postoperative care for surgical myotomy, including long-term follow-up.
If for any reason the endoscopic treatment is unable to be completed or infeasible, a standard laparoscopic treatment will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peroral endoscopic myotomy (POEM) | Experimental | Procedure: Procedure: Per Oral Endoscopic Myotomy (POEM)The Procedure: per oral endoscopic myotomy (POEM)will be performed on all patients in this single arm study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Candidate for a Heller myotomy
- No contra-indication to general anesthesia
- Their age is ≥18 years and ≤80 years
- Able to give written consent
Key exclusion criteria (6 listed)
- Previous intervention for achalasia: any of previous Heller myotomy, Botox injections, endoscopic myotomy
- Previous mediastinal surgery
- Any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow or hiatal hernia > 2cm.
- Body mass index (BMI) > 40
- Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
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 |
|---|---|---|
| Procedure: Per Oral Endoscopic Myotomy (POEM)lower esophageal sphincter muscle is sectioned through an unique endoscopic approach. | Procedure or surgery | peroral endoscopic myotomy (POEM) |
Primary outcome
feasibility of the POEM procedure in achalasia
Time frame: 1-6 months
Patients will be consecutively evaluated on effectiveness of the endoluminal procedure by conducting standard diagnostics including postoperative gastrografin swallow. After 6 months standard esophagogastroduodenoscopy (EGD), high-resolution manometry and pH impedance will be done and a Quality of Life questionnaire will be filled out. Results will be compared to historical data of 40 conventional laparoscopic Heller myotomies.
1 secondary outcome
complications
Time frame: 1-6 months
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 24 Sep 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.
Dennis Hong, MD principal investigator
St. Josephs' Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: Per Oral Endoscopic Myotomy (POEM) in people with Achalasia, run by McMaster University at 1 site in Canada.
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 4 inclusion and 6 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 24 Sep 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 Canada. 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.
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?
feasibility of the POEM procedure in achalasia (time frame: 1-6 months). 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 24 Sep 2015.