AchalasiaPOEMNCT02314741
Peroral Endoscopic Myotomy (POEM) for Esophageal Motility
A study testing POEM Procedure in people with Achalasia, run by University of Pennsylvania at 1 site in United States.
Trial summary
The investigators wish to monitor the adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Achalasia
- What is being tested?
- POEM Procedure
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = to 18 years of age
- Clinical diagnosis of achalasia
- A candidate for Heller myotomy
- Esophageal manometry and barium esophogram with findings supportive of achalasia diagnosis
- Women of childbearing potential: negative urine pregnancy test
- Able to undergo general anesthesia
- Willing and able to give informed consent
Who cannot join
- < 18 years of age
- Pregnancy
- Previous mediastinal or esophageal surgery
- Contraindications for esophagogastroduodenoscopy
- Presence of malignancy
- Coagulopathy (INR 1.5)
Show all 11Show fewer
- Thrombocytopenia (platelet count < 100K/microliter)
- ASA Score > Class II
- History of mental illness
- Any medical conditions as determined by the PI to be a contraindication to the procedure
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Peroral Endoscopic Myotomy (POEM) for Esophageal Motility in Patients With a Clinical Diagnosis of Achalasia
The investigators wish to monitor the adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet inclusion criteria.
The POEM procedure has been done in many hospitals without any research associated with it. Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first case to be proctored by an experienced operator. The PI will then proctor the other adopters. The investigators would like to evaluate the safety of it and the effectiveness of it. The investigators will use their symptom scores and radiology tests pre- and post-POEM to evaluate effectiveness.
Read the detailed description
An esophageal motility disorder is when muscular contractions become discoordinated or weak and interfere with movement of food down the esophagus. Some esophageal motility disorders persist long enough to cause severe problems requiring surgical intervention. Achalasia, one subtype of esophageal motility disorder that is a rare disease, can be defined by the esophageal sphincter and muscle unable to relax or dilate. Left untreated, symptoms such as difficulty swallowing, regurgitation, heartburn, and chest pain may easily turn into complications such as severe weight loss, malnutrition, coughing, pulmonary infection, pneumonia, and perforation of the esophagus. Diagnosis of esophageal achalasia can be determined by esophageal manometry and/or barium swallow esophagram. Treatment for achalasia includes balloon dilation, botulinum toxin injection and surgical intervention. Balloon dilation is performed by inserting a balloon through the esophageal sphincter, inflating the balloon, disrupting the esophageal muscle. Botox has also been known to successfully relax spastic muscle contractions of achalasia through direct injection into the esophageal muscle. Unfortunately, each alternative to surgical treatment often requires repeated administration to improve the symptoms of achalasia. Traditional treatment of achalasia has included open abdominal or thoracic surgical procedures to cut valve muscles between the esophagus and stomach (Heller Myotomy). Laparoscopic multi-port Heller myotomies have become the preferred approach, requiring 4 smaller abdominal incisions for placement of laparoscope equipment. Results of this laparoscopic technique have proven that although 2/3 of the patient population was successfully treated, a subset of this group still need repeat surgical procedures or balloon dilation. Recently, single-incision laparoscopic Heller myotomies have produced favorable results, with a single umbilical incision preferential to multiple-incision laparoscopy. We propose adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM) is expected to provide a less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes as the Heller myotomy and can be adopted safely and effectively at Penn Medicine.
- Conditions
- Achalasia
- Being tested
- POEM Procedure
- Keywords
- poem, per oral endoscopic myotomy, achalasia
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POEM ProcedureProcedure or surgery
Also called POEM, per oral endoscopic myotomy
The procedure is performed under anesthesia.The procedure involves endoscopic electrosurgical dissection with an Olympus triangular tip knife.The myotomy is usually ~6cm long \& averages 8-10cm. After the myotomy is performed the scope is withdrawn \& inserted into the lumen to inspect the mucosa, ensure mucosal integrity \& confirm easy passage of the endoscope through the LES consistent with an adequate myotomy. The mucosal entry site is usually 2-3cm long, \& is closed with 5-10 endoscopic clips. Patients are hospitalized after procedure for observation.The patient is given IV-nutrition until post-operative day 1. An esophagram is obtained. If no loss of mucosal integrity or leak is noted, a liquid diet is started, which is continued for several days before initiating a solid diet.
| Study group | Role | What they receive |
|---|---|---|
| POEM Treatment Arm | Experimental | Patients treated with the POEM (per-oral endoscopic myotomy) procedure. Receives: Procedure: POEM Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gather Standardized Data on Patients with Achalasia Who Have Been Treated with the POEM Procedure
The primary aim of this study is to assess safety and efficacy in the adoption of the POEM procedure compared to the typical Heller Myotomy used for the treatment of achalasia using standardized methods, including esophageal manometry, pre- and post- procedure barium swallow studies, as well as standardized measures of dysphagia symptoms due to achalasia (the Eckart score), and patient's medical records and self-reported symptoms.
Measured: About 12 months
Secondary outcomes (2)
Pre-Procedure versus Post-Procedure Barium Swallow Results in POEM Patients
Assess POEM procedure's efficacy as defined by improvement of barium swallow study and dysphagia symptoms associated with achalasia. Barium swallow study will compare pre- and post-operative esophageal emptying.
Measured: About 6 Months
Pre-Procedure Versus Post-Procedure Eckart Score Results in POEM Patients
Assess POEM procedure's efficacy as defined by improvement of dysphagia symptoms associated with achalasia. Dysphagia improvement will be assessed using a pre- and post-surgical standardized dysphagia scoring system known as an Eckart Score.
Measured: About 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
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 University of PennsylvaniaThe 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
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinay Chandrasekhara, MD, Principal investigator, University of PennsylvaniaGregory G Ginsberg, MD, Principal investigator, University of PennsylvaniaGary W Falk, MD, MS, Principal investigator, University of PennsylvaniaMichael Kochman, MD, Principal investigator, University of PennsylvaniaDavid C Metz, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314741
- Sponsor's protocol ID
- 819130
- Acronym
- POEM
- Status last verified
- Feb 2018
- First submitted
- 17 Jul 2014
- Last updated
- 19 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroral Endoscopic Myotomy (POEM) for Esophageal Motility in Patients With a Clinical Diagnosis of Achalasia
- ClinicalTrials.gov ID
- NCT02314741
- Acronym / sponsor ID
- POEM / 819130
- Conditions
- Achalasia
- Keywords
- poem, per oral endoscopic myotomy, achalasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Dec 2014 (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.
The investigators wish to monitor the adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet inclusion criteria.
The POEM procedure has been done in many hospitals without any research associated with it. Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first case to be proctored by an experienced operator. The PI will then proctor the other adopters. The investigators would like to evaluate the safety of it and the effectiveness of it. The investigators will use their symptom scores and radiology tests pre- and post-POEM to evaluate effectiveness.
Detailed description
An esophageal motility disorder is when muscular contractions become discoordinated or weak and interfere with movement of food down the esophagus. Some esophageal motility disorders persist long enough to cause severe problems requiring surgical intervention. Achalasia, one subtype of esophageal motility disorder that is a rare disease, can be defined by the esophageal sphincter and muscle unable to relax or dilate. Left untreated, symptoms such as difficulty swallowing, regurgitation, heartburn, and chest pain may easily turn into complications such as severe weight loss, malnutrition, coughing, pulmonary infection, pneumonia, and perforation of the esophagus. Diagnosis of esophageal achalasia can be determined by esophageal manometry and/or barium swallow esophagram. Treatment for achalasia includes balloon dilation, botulinum toxin injection and surgical intervention. Balloon dilation is performed by inserting a balloon through the esophageal sphincter, inflating the balloon, disrupting the esophageal muscle. Botox has also been known to successfully relax spastic muscle contractions of achalasia through direct injection into the esophageal muscle. Unfortunately, each alternative to surgical treatment often requires repeated administration to improve the symptoms of achalasia. Traditional treatment of achalasia has included open abdominal or thoracic surgical procedures to cut valve muscles between the esophagus and stomach (Heller Myotomy). Laparoscopic multi-port Heller myotomies have become the preferred approach, requiring 4 smaller abdominal incisions for placement of laparoscope equipment. Results of this laparoscopic technique have proven that although 2/3 of the patient population was successfully treated, a subset of this group still need repeat surgical procedures or balloon dilation. Recently, single-incision laparoscopic Heller myotomies have produced favorable results, with a single umbilical incision preferential to multiple-incision laparoscopy. We propose adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM) is expected to provide a less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes as the Heller myotomy and can be adopted safely and effectively at Penn Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POEM Treatment Arm | Experimental | Procedure: POEM ProcedurePatients treated with the POEM (per-oral endoscopic myotomy) procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > or = to 18 years of age
- Clinical diagnosis of achalasia
- A candidate for Heller myotomy
- Esophageal manometry and barium esophogram with findings supportive of achalasia diagnosis
- Women of childbearing potential: negative urine pregnancy test
Key exclusion criteria (11 listed)
- < 18 years of age
- Pregnancy
- Previous mediastinal or esophageal surgery
- Contraindications for esophagogastroduodenoscopy
- Presence of malignancy
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 |
|---|---|---|
| POEM ProcedureAlso: POEM, per oral endoscopic myotomyThe procedure is performed under anesthesia.The procedure involves endoscopic electrosurgical dissection with an Olympus triangular tip knife.The myotomy is usually ~6cm long \& averages 8-10cm. After the myotomy is performed the scope is withdrawn \& inserted into the lumen to inspect the mucosa, ensure mucosal integrity \& confirm easy passage of the endoscope through the LES consistent with an adequate myotomy. The mucosal entry site is usually 2-3cm long, \& is closed with 5-10 endoscopic clips. Patients are hospitalized after procedure for observation.The patient is given IV-nutrition until post-operative day 1. An esophagram is obtained. If no loss of mucosal integrity or leak is noted, a liquid diet is started, which is continued for several days before initiating a solid diet. | Procedure or surgery | POEM Treatment Arm |
Primary outcome
Gather Standardized Data on Patients with Achalasia Who Have Been Treated with the POEM Procedure
Time frame: About 12 months
The primary aim of this study is to assess safety and efficacy in the adoption of the POEM procedure compared to the typical Heller Myotomy used for the treatment of achalasia using standardized methods, including esophageal manometry, pre- and post- procedure barium swallow studies, as well as standardized measures of dysphagia symptoms due to achalasia (the Eckart score), and patient's medical records and self-reported symptoms.
2 secondary outcomes
Pre-Procedure versus Post-Procedure Barium Swallow Results in POEM Patients
Time frame: About 6 Months
Pre-Procedure Versus Post-Procedure Eckart Score Results in POEM Patients
Time frame: About 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 19 Feb 2018.
Related trials for Achalasia
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PREcision MEDicine In Achalasia (PREMEDIA)
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PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
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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.
Vinay Chandrasekhara, MD principal investigator
University of Pennsylvania
Gregory G Ginsberg, MD principal investigator
University of Pennsylvania
Gary W Falk, MD, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POEM Procedure in people with Achalasia, run by University of Pennsylvania 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 7 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 19 Feb 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?
Gather Standardized Data on Patients with Achalasia Who Have Been Treated with the POEM Procedure (time frame: About 12 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 19 Feb 2018.