AchalasiaNCT02454335
POEM Anterior Versus Posterior Approach
A study testing Peroral Endoscopic Myotomy in people with Achalasia, run by Johns Hopkins University at 1 site in United States.
Trial summary
Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal achalasia, performed by GI endoscopist without cutting any surface of the human body. The main constituent of the procedure is the myotomy part, through which the endoscopist cuts the muscle fibers in the submucosa. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Achalasia
- What is being tested?
- Peroral Endoscopic Myotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Nov 2017
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient age greater than 18 years old
- Confirmed diagnosis of achalasia via high resolution esophageal manometry (HREM)
Who cannot join
- Previous surgery of the esophagus or stomach
- Active severe esophagitis
- Large lower esophageal diverticula
- Large > 3cm hiatal hernia
- Sigmoid esophagus
- Known gastroesophageal malignancy
Show all 11Show fewer
- Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
- Cirrhosis with portal hypertension, varices, and/or ascites
- Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
- Acute gastrointestinal bleeding
- Uncorrectable coagulopathy defined by INR > 1.5 or platelet < 50
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Outcome and Complications of Anterior Versus Posterior Myotomy in Per-oral Endoscopic Myotomy (POEM) Endoscopic Procedure for Treatment of Achalasia: Randomized Single Blinded Clinical Trial
Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal achalasia, performed by GI endoscopist without cutting any surface of the human body. The main constituent of the procedure is the myotomy part, through which the endoscopist cuts the muscle fibers in the submucosa. Since this procedure is completely new to the area of treatment of achalasia, it is unknown whether a posterior or an anterior myotomy is better in relieving the symptoms. Thenceforth, this study aims at randomizing patients with achalasia presenting for POEM to getting either the posterior or the anterior myotomy. Patients will be followed up for symptoms and complications; data will be extracted and the appropriate analysis will be employed to determine if there is any difference of outcome between the two techniques of myotomy.
Read the detailed description
Peroral Endoscopic Myotomy (POEM) is an effective, minimally-invasive treatment for achalasia that has been adopted over the past few years. As more programs attempt to adopt the novel technique, there is an increased need for trials to help guide the growth of the procedure. Review of the current literature reveals that most endoscopists prefer an anterior approach, with an incision in the anterior/ anterolateral wall of the esophagus. This approach has been used with tremendous success in decreasing the symptoms of dysphagia and lowering esophageal sphincter (LES) pressure since the first description of the procedure in humans in 2010. However, it can be technically challenging in patients with anterior scarring from prior surgery or radiation, in whom a posterior approach has typically been used. Alternatively, the posterior approach, with incision in the posterolateral wall of the esophagus, has been adopted with great success by several endoscopists as the primary approach to myotomy. Reports involving the posterior approach have also shown significant symptom relief as defined by symptoms score (Eckardt score) < 3, decreased LES pressure, and low complication rates.
However, despite high rates of technical and clinical success, the posterior approach has not been as widely adopted as the anterior approach. Without comparison of the two approaches in terms of efficacy and safety, the optimal technique to myotomy for POEM is yet to be defined. The investigators main hypothesis is that the posterior myotomy is as efficacious as the anterior myotomy in terms of improvement of achalasia symptoms as indicated by reduction in the Eckardt score and LES pressure. Adaptation of both techniques may increase options in approach for routine POEM and increase the number of patients that are able to undergo the procedure, thereby promoting its applicability.
- Conditions
- Achalasia
- Being tested
- Peroral Endoscopic 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.
Peroral Endoscopic MyotomyProcedure or surgery
Also called POEM
The intervention is the POEM procedure performed by either anterior approach or posterior approach orientation of the incision for mucosal entry.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Approach | Active comparator | For the anterior approach, an incision will be made in the 1 to 2 o'clock position of the esophageal wall. Receives: Procedure: Peroral Endoscopic Myotomy |
| Posterior Approach | Active comparator | For the posterior approach, a mucosal incision will be made at the 5 to 6 o'clock position Receives: Procedure: Peroral Endoscopic Myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eckardt Score
The standardized clinical scoring system for achalasia will be assessed at 2 weeks, 3 months, 6 months, and 1 year post procedure. The score is based on the results of a self- administered questionnaire using 4 items related to digestive symptoms including weight loss, dysphagia, retrosternal pain, and regurgitation. Each item is rated from 0 to 3 (0= none, 1= occasional, 2=daily, 3=with every meal).
Measured: up to 24 months
Secondary outcomes (11)
Rate of GERD by pH-impedance
This is assessed by the DeMeester score. The score is comprised of the following: Percent total time pH < 4, Percent Upright time pH < 4, Percent Supine time pH < 4, Number of reflux episodes, Number of reflux episodes ≥ 5 min, Longest reflux episode (minutes). The abnormal reflux is defined as DeMeester score >14.72
Measured: up to 24 months
Quality of Life by QoL S36 questionnaire
The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.
Measured: up to 2 years
Dysphagia by the Dysphagia Score
Dysphagia scoring system scores dysphagia as follows:
0 = able to eat normal diet / no dysphagia; 1 = able to swallow some solid foods; 2 = able to swallow only semi solid foods; 3 = able to swallow liquids only; 4 = unable to swallow anything / total dysphagia.
Measured: up to 24 months
Postoperative pain by VAS analogue scale
The visual analogue scales scores the severity of the pain from zero (minimum) to 10 (maximum).
Measured: 2 years
Analgesic use by Analgesic Quantification Algorithm
Analgesic Quantification Algorithm scoring scores analgesic use from zero (minimum) to 7 (maximum) as follows:
0= No analgesic; 1= Non-opioid analgesics; 2= Weak opioids (For example, codeine and tramadol); 3= Strong opioids ≤75 mg OME per day; 4= Strong opioids >75-150 mg OME per day; 5= Strong opioids >150-300 mg OME per day; 6= Strong opioids >300-600 mg OME per day ; 7=Strong opioids >600 mg OME per day
Measured: up to 24 months
Operative and post-operative complications
Measured: up to 2 years
Hospital stay in days
Measured: up to 24 months
LES pressure by Manometry
Measured: up to 2 years
Total procedure time and times of different steps
Measured: up to 24 months
Technical success
Defined as completion of the procedure using the assigned approach
Measured: up to 24 months
Ease of procedure measured by the Lickerdt scale
The ease of the procedure scored by the endoscopist on a Likert scale rated from 1 (easy) to 5 (impossible).
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454335
- Sponsor's protocol ID
- NA_00093759
- Status last verified
- Dec 2017
- First submitted
- 10 May 2015
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khashab MA, Sanaei O, Rivory J, Eleftheriadis N, Chiu PWY, Shiwaku H, Ogihara K, Ismail A, Abusamaan MS, El Zein MH, Wong VW, Billioux VG, Kumbhari V, Kalloo AN, Ponchon T, Pioche M. Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial. Gastrointest Endosc. 2020 Feb;91(2):288-297.e7. doi: 10.1016/j.gie.2019.07.034. Epub 2019 Aug 10.
PubMed 31408652
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome and Complications of Anterior Versus Posterior Myotomy in Per-oral Endoscopic Myotomy (POEM) Endoscopic Procedure for Treatment of Achalasia: Randomized Single Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT02454335
- Acronym / sponsor ID
- NA_00093759
- Conditions
- Achalasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 27 May 2015 (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.
Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal achalasia, performed by GI endoscopist without cutting any surface of the human body. The main constituent of the procedure is the myotomy part, through which the endoscopist cuts the muscle fibers in the submucosa. Since this procedure is completely new to the area of treatment of achalasia, it is unknown whether a posterior or an anterior myotomy is better in relieving the symptoms. Thenceforth, this study aims at randomizing patients with achalasia presenting for POEM to getting either the posterior or the anterior myotomy. Patients will be followed up for symptoms and complications; data will be extracted and the appropriate analysis will be employed to determine if there is any difference of outcome between the two techniques of myotomy.
Detailed description
Peroral Endoscopic Myotomy (POEM) is an effective, minimally-invasive treatment for achalasia that has been adopted over the past few years. As more programs attempt to adopt the novel technique, there is an increased need for trials to help guide the growth of the procedure. Review of the current literature reveals that most endoscopists prefer an anterior approach, with an incision in the anterior/ anterolateral wall of the esophagus. This approach has been used with tremendous success in decreasing the symptoms of dysphagia and lowering esophageal sphincter (LES) pressure since the first description of the procedure in humans in 2010. However, it can be technically challenging in patients with anterior scarring from prior surgery or radiation, in whom a posterior approach has typically been used. Alternatively, the posterior approach, with incision in the posterolateral wall of the esophagus, has been adopted with great success by several endoscopists as the primary approach to myotomy. Reports involving the posterior approach have also shown significant symptom relief as defined by symptoms score (Eckardt score) < 3, decreased LES pressure, and low complication rates.
However, despite high rates of technical and clinical success, the posterior approach has not been as widely adopted as the anterior approach. Without comparison of the two approaches in terms of efficacy and safety, the optimal technique to myotomy for POEM is yet to be defined. The investigators main hypothesis is that the posterior myotomy is as efficacious as the anterior myotomy in terms of improvement of achalasia symptoms as indicated by reduction in the Eckardt score and LES pressure. Adaptation of both techniques may increase options in approach for routine POEM and increase the number of patients that are able to undergo the procedure, thereby promoting its applicability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Approach | Active comparator | Procedure: Peroral Endoscopic MyotomyFor the anterior approach, an incision will be made in the 1 to 2 o'clock position of the esophageal wall. |
| Posterior Approach | Active comparator | Procedure: Peroral Endoscopic MyotomyFor the posterior approach, a mucosal incision will be made at the 5 to 6 o'clock position |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient age greater than 18 years old
- Confirmed diagnosis of achalasia via high resolution esophageal manometry (HREM)
Key exclusion criteria (11 listed)
- Previous surgery of the esophagus or stomach
- Active severe esophagitis
- Large lower esophageal diverticula
- Large > 3cm hiatal hernia
- Sigmoid esophagus
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 MyotomyAlso: POEMThe intervention is the POEM procedure performed by either anterior approach or posterior approach orientation of the incision for mucosal entry. | Procedure or surgery | Anterior Approach, Posterior Approach |
Primary outcome
Change in Eckardt Score
Time frame: up to 24 months
The standardized clinical scoring system for achalasia will be assessed at 2 weeks, 3 months, 6 months, and 1 year post procedure. The score is based on the results of a self- administered questionnaire using 4 items related to digestive symptoms including weight loss, dysphagia, retrosternal pain, and regurgitation. Each item is rated from 0 to 3 (0= none, 1= occasional, 2=daily, 3=with every meal).
11 secondary outcomes
Rate of GERD by pH-impedance
Time frame: up to 24 months
Quality of Life by QoL S36 questionnaire
Time frame: up to 2 years
Dysphagia by the Dysphagia Score
Time frame: up to 24 months
Postoperative pain by VAS analogue scale
Time frame: 2 years
Analgesic use by Analgesic Quantification Algorithm
Time frame: up to 24 months
Operative and post-operative complications
Time frame: up to 2 years
Hospital stay in days
Time frame: up to 24 months
LES pressure by Manometry
Time frame: up to 2 years
Total procedure time and times of different steps
Time frame: up to 24 months
Technical success
Time frame: up to 24 months
Ease of procedure measured by the Lickerdt scale
Time frame: up to 24 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 2 Jan 2018.
- Derived from this study: PubMed 31408652Khashab MA, Sanaei O, Rivory J, Eleftheriadis N, Chiu PWY, Shiwaku H, Ogihara K, Ismail A, Abusamaan MS, El Zein MH, Wong VW, Billioux VG, Kumbhari V, Kalloo AN, Ponchon T, Pioche M. Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial. Gastrointest Endosc. 2020 Feb;91(2):288-297.e7. doi: 10.1016/j.gie.2019.07.034. Epub 2019 Aug 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peroral Endoscopic Myotomy in people with Achalasia, run by Johns Hopkins University at 1 site in United States.
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 2 inclusion and 11 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 2 Jan 2018. 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 United States. 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?
Change in Eckardt Score (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454335, which also lists 1 linked publication.
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 2 Jan 2018; AzTrials last refreshed its copy on 1 Nov 2026.