Esophagogastric Junction Outflow ObstructionNCT01942018
Per Oral Endoscopic Myotomy (POEM) for Esophagogastric Junction Outflow Obstruction (EGOO)
A study testing POEM in people with Esophagogastric Junction Outflow Obstruction, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to study an endoscopic procedure called "POEM" as a less invasive alternative to surgery in people with esophagogastric junction outlet obstruction (EGOO). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophagogastric Junction Outflow Obstruction
- What is being tested?
- 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
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to May 2020
- 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
- Consecutive adult patients (18-70 years of age) with symptomatic dysphagia (dysphagia score ≥2) EGOO that is diagnosed by high resolution manometry.
- Ability to give informed consent.
Who cannot join
- Unable to give informed consent
- Pregnant or breastfeeding women (all female patients if child-bearing age will undergo urine pregnancy testing prior to endoscopy)
- Acute gastrointestinal bleeding
- Coagulopathy defined by prothrombin time < 50% of control; partial thromboplastin time (PTT) > 50 sec, or international normalized ratio (INR) > 1.5), on chronic anticoagulation, or platelet count <75,000
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
- Prior esophageal or gastric surgeries
Show all 16Show fewer
- Cirrhosis with portal hypertension, varices, and/or ascites
- Active Esophagitis
- Hiatal hernia larger than 2cm
- Barrett's esophagus
- Eosinophilic esophagitis
- Esophageal stricture
- Esophageal malignancy
- Large esophageal diverticulum
- Mechanical obstruction to esophageal outflow or infiltrative esophageal or gastric disorders.
- Prior esophageal Botox injection
Trial locations and contacts
1 site in 1 country.
About this study
This research is being done to study an endoscopic procedure called "POEM" as a less invasive alternative to surgery in people with esophagogastric junction outlet obstruction (EGOO).
Read the detailed description
Patients with EGOO have difficulty swallowing and/or chest pain. Previously we were not able to distinguish this disease from achalasia. Achalasia is a disease which is characterized by a progressive difficulty with swallowing. It is caused by failure of relaxation of the lower esophageal sphincter (sphincter between esophagus and stomach) along with an essentially aperistaltic esophageal body.
However, EGOO patients have abnormal lower esophageal sphincter relaxation with some preserved peristaltic activity. Because they have some peristalsis, these patients are not diagnosed with achalasia.
Currently, a new diagnostic method, known as high-resolution manometry (HRM), can identify EGOO patients. EGOO patients usually do not respond well to medical treatment and surgery is required in most cases to reduce the pressure of lower esophageal sphincter muscles. This procedure is called "Heller myotomy".
Recently, a new endoscopic method for reducing lower esophageal sphincter pressure has been developed. This method, per-oral endoscopic myotomy (POEM) is now being performed clinically throughout the world, including Johns Hopkins Hospital. The technique utilizes a flexible endoscope to tunnel beneath the esophageal surface layer and cutting muscle fibers of the lower esophagus and upper stomach. POEM is an alternative to invasive surgery with fewer complications. POEM is performed safely at Johns Hopkins Hospital for achalasia patients. Outcomes of POEM have been excellent with greater than 90% positively responding to endoscopic myotomy. Patients with EGOO are being diagnosed more often due to increased use of HRM. They respond poorly to endoscopic therapies but well to surgical myotomy. POEM is the endoscopic equivalent to surgical intervention and represents a less invasive approach to treating these patients.
- Being tested
- POEM
- Keywords
- esophagogastric junction outflow obstruction, EGOO, Per oral endoscopic myotomy, POEM, Gastroesophageal reflux disease, GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POEMProcedure or surgery
Patients will receive Per oral endoscopic myotomy (POEM) for symptomatic gastroesophageal junction outflow obstruction (EGOO)
| Study group | Role | What they receive |
|---|---|---|
| EGOO | Experimental | Patients presenting with symptomatic gastroesophageal junction outflow obstruction (EGOO)who will be treated with Per oral endoscopic myotomy (POEM) Receives: Procedure: POEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dysphagia severity
Dysphagia will be measured by Dysphagia score and Eckhardt score at 2 and 6 months after the procedure (The Eckhardt score takes into consideration symptoms of dysphagia, chest pain, regurgitation and chest pain)
Measured: 2 and 6 months
Secondary outcomes (7)
Resolution in Esophago-gastric junction (EGJ) outflow obstruction by HRM performed 2 months after the procedure
Measured: 2 months
Change in participants' quality of life
Improvement in patient's quality of life as reflected by Short Form-36 questionnaire at 2 and 6 months after the procedure
Measured: 2 and 6 months
Complication rate
Complications include any of the following (full thickness perforations, unplanned mucosectomies, immediate and delayed bleeding).
Measured: 2 years
Length of hospital stay
Measured: 2 years
Procedural times
Measured: 2 years
Post procedural Gastroesophageal reflux disease (GERD)
Frequency of post-procedural GERD as documented by either 24 hr ph/Impedence testing, 48 hr Bravo (performed at 2 months), or esophagogastroduodenoscopy (EGD) with evidence of esophagitis
Measured: 2 months
Time to resume normal diet
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startMay 2015
- Primary completionApr 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric Junction Outflow ObstructionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouen A Khashab, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942018
- Sponsor's protocol ID
- NA_00082967
- Status last verified
- May 2020
- First submitted
- 5 Sep 2013
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Per Oral Endoscopic Myotomy (POEM) for Esophagogastric Junction Outflow Obstruction (EGOO)
- ClinicalTrials.gov ID
- NCT01942018
- Acronym / sponsor ID
- NA_00082967
- Keywords
- esophagogastric junction outflow obstruction, EGOO, Per oral endoscopic myotomy, POEM, Gastroesophageal reflux disease, GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 13 Sep 2013 (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 research is being done to study an endoscopic procedure called "POEM" as a less invasive alternative to surgery in people with esophagogastric junction outlet obstruction (EGOO).
Detailed description
Patients with EGOO have difficulty swallowing and/or chest pain. Previously we were not able to distinguish this disease from achalasia. Achalasia is a disease which is characterized by a progressive difficulty with swallowing. It is caused by failure of relaxation of the lower esophageal sphincter (sphincter between esophagus and stomach) along with an essentially aperistaltic esophageal body.
However, EGOO patients have abnormal lower esophageal sphincter relaxation with some preserved peristaltic activity. Because they have some peristalsis, these patients are not diagnosed with achalasia.
Currently, a new diagnostic method, known as high-resolution manometry (HRM), can identify EGOO patients. EGOO patients usually do not respond well to medical treatment and surgery is required in most cases to reduce the pressure of lower esophageal sphincter muscles. This procedure is called "Heller myotomy".
Recently, a new endoscopic method for reducing lower esophageal sphincter pressure has been developed. This method, per-oral endoscopic myotomy (POEM) is now being performed clinically throughout the world, including Johns Hopkins Hospital. The technique utilizes a flexible endoscope to tunnel beneath the esophageal surface layer and cutting muscle fibers of the lower esophagus and upper stomach. POEM is an alternative to invasive surgery with fewer complications. POEM is performed safely at Johns Hopkins Hospital for achalasia patients. Outcomes of POEM have been excellent with greater than 90% positively responding to endoscopic myotomy. Patients with EGOO are being diagnosed more often due to increased use of HRM. They respond poorly to endoscopic therapies but well to surgical myotomy. POEM is the endoscopic equivalent to surgical intervention and represents a less invasive approach to treating these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGOO | Experimental | Procedure: POEMPatients presenting with symptomatic gastroesophageal junction outflow obstruction (EGOO)who will be treated with Per oral endoscopic myotomy (POEM) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive adult patients (18-70 years of age) with symptomatic dysphagia (dysphagia score ≥2) EGOO that is diagnosed by high resolution manometry.
- Ability to give informed consent.
Key exclusion criteria (16 listed)
- Unable to give informed consent
- Pregnant or breastfeeding women (all female patients if child-bearing age will undergo urine pregnancy testing prior to endoscopy)
- Acute gastrointestinal bleeding
- Coagulopathy defined by prothrombin time < 50% of control; partial thromboplastin time (PTT) > 50 sec, or international normalized ratio (INR) > 1.5), on chronic anticoagulation, or platelet count <75,000
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
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 |
|---|---|---|
| POEMPatients will receive Per oral endoscopic myotomy (POEM) for symptomatic gastroesophageal junction outflow obstruction (EGOO) | Procedure or surgery | EGOO |
Primary outcome
Change in dysphagia severity
Time frame: 2 and 6 months
Dysphagia will be measured by Dysphagia score and Eckhardt score at 2 and 6 months after the procedure (The Eckhardt score takes into consideration symptoms of dysphagia, chest pain, regurgitation and chest pain)
7 secondary outcomes
Resolution in Esophago-gastric junction (EGJ) outflow obstruction by HRM performed 2 months after the procedure
Time frame: 2 months
Change in participants' quality of life
Time frame: 2 and 6 months
Complication rate
Time frame: 2 years
Length of hospital stay
Time frame: 2 years
Procedural times
Time frame: 2 years
Post procedural Gastroesophageal reflux disease (GERD)
Time frame: 2 months
Time to resume normal diet
Time frame: 2 years
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 28 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Mouen A Khashab, MD principal investigator
Johns Hopkins University
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 in people with Esophagogastric Junction Outflow Obstruction, 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 16 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 28 May 2020. 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 dysphagia severity (time frame: 2 and 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 28 May 2020.