AchalasiaNCT01438398
Efficacy & Safety of Submucosal Endoscopic Myotomy With Mucosal Flap (SEMF) in the Treatment of Patients With Achalasia
A study testing Submucosal endoscopic myotomy with mucosal flap technique and Submucosal Endoscopic Mucosal Flap (SEMF) technique in people with Achalasia and Dysphagia, run by Winthrop University Hospital at 1 site in United States.
Trial summary
The purpose of this study is to learn about the safety and usefulness of a procedure called endoscopic submucosal myotomy, which is a new technique in the treatment of achalasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Submucosal endoscopic myotomy with mucosal flap technique and Submucosal Endoscopic Mucosal Flap (SEMF) technique
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2011to 22 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years or older, male or female, belonging to any race or ethnic origin
- Patients with manometric positive diagnosis of achalasia, with corresponding symptoms of dysphagia, regurgitation of food or chest pain
- Patients who are willing and competent to sign Informed Consent and to comply with study related visits and procedures
Who cannot join
- Patients who are below 18 years of age
- Presence of coagulopathy
- Pregnancy
- Patients who, in the investigator's opinion, are medically unstable, are unable to give informed consent, or whose risks outweigh the benefits of participating in the study
- Vulnerable subjects: Prisoners, persons with decisional incapacity, and any person who are directly involved in the study, including their immediate family members, and anybody who may have any conflict of interest such as employees of ERBE, USA.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: A Prospective, Single Center, Proof of Concept Pilot Study of the Efficacy and Safety of Submucosal Endoscopic Myotomy With Mucosal Flap (SEMF) Technique in the Treatment of Patients With Achalasia
The purpose of this study is to learn about the safety and usefulness of a procedure called endoscopic submucosal myotomy, which is a new technique in the treatment of achalasia. Achalasia is a disorder involving the lack of smooth muscle relaxation and sustained high pressure in the sphincter (muscle) of the lower esophagus. This may result in symptoms such as difficulty in swallowing, chest pain, regurgitation of food and eventually, weight loss.
For more than a decade, a laparoscopic surgical procedure known as Heller myotomy has been the primary treatment for achalasia in patients with low surgical risk. In Heller myotomy, the surgeon makes three to four small abdominal incisions, inserts tube-like instruments through them, and once inside, the junction between the esophagus and stomach is found, a lengthwise incision is made on the muscular ring surrounding the lower esophageal sphincter which weakens the muscle and the lower esophageal sphincter or muscle (LES) is then able to open more easily. However, there is an emerging field known as natural orifice (opening) transluminal (through the lumen) endoscopic surgery (NOTES). This approach involves passing an endoscope - a thin tube with a built-in camera, light and minuscule tools through the natural opening in the body, like the mouth in order to perform less invasive surgery without any external wounds or scars. The procedure is done using the Submucosal Endoscopy with Mucosal Flap (SEMF) technique which involves passing an endoscope through the mouth into the esophagus, where a small incision is made on the lining of the esophagus, known as the mucosa. A balloon is then inserted and dilated in the submucosa - the layer between the inner lining of the esophagus and the outer wall consisting of the muscle of the esophagus. Dilation of the balloon in the submucosa creates a tunnel that allows insertion of the endoscope and access to the muscle of the lower esophageal sphincter (LES). A long incision is then carefully made on the posterior portion of the muscular ring that forms the LES. The incision divides the muscle fibers of the LES, which weakens the muscle, allowing for the easier passage of food while preserving some valve function to prevent reflux of acid from the stomach into the esophagus.
The expected duration of participation is up to 10 years from the time study participants undergo the endoscopic surgical procedure.
Read the detailed description
The safety of the procedure and feasibility of the study will be measured by improvement in subjects' symptoms score, decrease in LES pressure, as well as the number and severity of complications or adverse events experienced by the subjects. A modified Eckhardt dysphagia assessment tool will be used in grading the dysphagia symptoms.
- Being tested
- Submucosal endoscopic myotomy with mucosal flap technique, Submucosal Endoscopic Mucosal Flap (SEMF) technique
- Keywords
- Submucosal endoscopic myotomy, Per Oral Endoscopic Myotomy, Natural Orifice Transluminal Endoscopic Surgery
- Medical subject headings
- Esophageal Achalasia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submucosal endoscopic myotomy with mucosal flap techniqueProcedure or surgery
Also called Per Oral Endoscopic Myotomy (POEM), Natural Orifice Transluminal Endoscopic Surgery (NOTES)
Submucosal Endoscopy with Mucosal Flap (SEMF) technique involves the following: (1) injecting 0.9 % normal saline solution to create a submucosal cushion, (2) tiny cut is made into the cushion, (3) Balloon will be used to dilate the opening and allow passage of endoscope in the submucosal space, (4) Upon direct visualization of the muscle fibers, the doctor will cut the circular layers of the diseased muscles, and (5) Tiny clips will be used to close the tiny cut made earlier.
Submucosal Endoscopic Mucosal Flap (SEMF) techniqueProcedure or surgery
Also called Per Oral Endoscopic Myotomy, Natural Orifice Transluminal Endoscopic Surgery
| Study group | Role | What they receive |
|---|---|---|
| Submucosal Endoscopic Mucosal Flap Technique | Other | Submucosal Endoscopic Mucosal Flap Technique Receives: Procedure: Submucosal endoscopic myotomy with mucosal flap technique; Procedure: Submucosal Endoscopic Mucosal Flap (SEMF) technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower esophageal sphincter pressure (LES)
High Resolution Esophageal Manometry will be done at 3 months to measure LES and the result will be compared to baseline or pre-endoscopic myotomy LES pressure.
Measured: at 3 months post endoscopic myotomy
Change in frequency of dysphagia
Swallowing difficulty (dysphagia) will be assessed using the Modified Eckhardt Dysphagia Assessment Tool which includes asking the patient how often he/she experiences swallowing difficulty (0 = none, 1 = occasional, 2 = daily, and 3 = every meal. The score will be compared to pre-myotomy score.
Measured: 4 weeks post procedure
Change in frequency of Regurgitation
Patient will be asked how often he/she brings up swallowed liquid/solid food or regurgitates (0 = none, 1 = occasional, 2 = daily, and 3 = every meal. The score will be compared to the score prior to the procedure.
Measured: 4 weeks post procedure
Change in frequency of chest pain
The patient will be asked how often he/she experiences chest pain and the frequency (0 = none, 1 = occasional, 2 = daily, and 3 = every meal. The score will be compared to pre-myotomy score.
Measured: 4 weeks post procedure
Presence of perforation
Presence of perforation that is seen during the endoscopic procedure.
Measured: During endoscopic myotomy procedure
Presence of bleeding
Occurence of bleeding during the procedure.
Measured: During endoscopic myotomy procedure
Presence of mediastinal emphysema
Presence of mediastinal emphysema will be recorded.
Measured: During endoscopic myotomy procedure
Presence of Infection
Presence of infection within the first 4 weeks post myotomy will be recorded.
Measured: 4 weeks post procedure
Development of stricture at the myotomy site.
Development of stricture will be assessed by performing an upper endoscopy for patients with change in their Modified Dysphagia Score.
Measured: 3 months post procedure
Secondary outcomes (3)
Presence and frequency of heartburn
The patient will be asked for presence or absence of heartburn. If present, he/she will be asked for frequency (0 = none, 1 = occasional, 2 = daily, and 3 = every meal). The score will be compared to pre-myotomy score.
Measured: 4 weeks post procedure
Frequency of use of antacids (PPI, H-2 antagonists)
The patient will be asked if he/she is using any type of antacid. If using antacid, he/she will be asked how often he/she is using it (0 = none, 1 = occasional, 2 = daily, and 3 = every meal). The score will be compared to pre-myotomy score.
Measured: 4 weeks post procedure
Change in patient's weight
Post myotomy weight will be measured and recorded and compared to pre-myotomy weight.
Measured: At 3, 6, 9, and 12 months post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study start8 Apr 2011
- Primary completion6 Jan 2015
- Study completion22 Oct 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.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Stavropoulos, MD, Winthrop University Hospital
- Investigators
- Stavros N Stavropoulos, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438398
- Sponsor's protocol ID
- 10035
- Status last verified
- May 2017
- First submitted
- 28 Mar 2011
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Proof of Concept Pilot Study of the Efficacy and Safety of Submucosal Endoscopic Myotomy With Mucosal Flap (SEMF) Technique in the Treatment of Patients With Achalasia
- ClinicalTrials.gov ID
- NCT01438398
- Acronym / sponsor ID
- 10035
- Keywords
- Submucosal endoscopic myotomy, Per Oral Endoscopic Myotomy, Natural Orifice Transluminal Endoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2011 (actual)
- Primary completion
- 6 Jan 2015 (actual)
- Study completion
- 22 Oct 2015 (actual)
- First posted
- 22 Sep 2011 (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 purpose of this study is to learn about the safety and usefulness of a procedure called endoscopic submucosal myotomy, which is a new technique in the treatment of achalasia. Achalasia is a disorder involving the lack of smooth muscle relaxation and sustained high pressure in the sphincter (muscle) of the lower esophagus. This may result in symptoms such as difficulty in swallowing, chest pain, regurgitation of food and eventually, weight loss.
For more than a decade, a laparoscopic surgical procedure known as Heller myotomy has been the primary treatment for achalasia in patients with low surgical risk. In Heller myotomy, the surgeon makes three to four small abdominal incisions, inserts tube-like instruments through them, and once inside, the junction between the esophagus and stomach is found, a lengthwise incision is made on the muscular ring surrounding the lower esophageal sphincter which weakens the muscle and the lower esophageal sphincter or muscle (LES) is then able to open more easily. However, there is an emerging field known as natural orifice (opening) transluminal (through the lumen) endoscopic surgery (NOTES). This approach involves passing an endoscope - a thin tube with a built-in camera, light and minuscule tools through the natural opening in the body, like the mouth in order to perform less invasive surgery without any external wounds or scars. The procedure is done using the Submucosal Endoscopy with Mucosal Flap (SEMF) technique which involves passing an endoscope through the mouth into the esophagus, where a small incision is made on the lining of the esophagus, known as the mucosa. A balloon is then inserted and dilated in the submucosa - the layer between the inner lining of the esophagus and the outer wall consisting of the muscle of the esophagus. Dilation of the balloon in the submucosa creates a tunnel that allows insertion of the endoscope and access to the muscle of the lower esophageal sphincter (LES). A long incision is then carefully made on the posterior portion of the muscular ring that forms the LES. The incision divides the muscle fibers of the LES, which weakens the muscle, allowing for the easier passage of food while preserving some valve function to prevent reflux of acid from the stomach into the esophagus.
The expected duration of participation is up to 10 years from the time study participants undergo the endoscopic surgical procedure.
Detailed description
The safety of the procedure and feasibility of the study will be measured by improvement in subjects' symptoms score, decrease in LES pressure, as well as the number and severity of complications or adverse events experienced by the subjects. A modified Eckhardt dysphagia assessment tool will be used in grading the dysphagia symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Submucosal Endoscopic Mucosal Flap Technique | Other | Procedure: Submucosal endoscopic myotomy with mucosal flap technique, Procedure: Submucosal Endoscopic Mucosal Flap (SEMF) techniqueSubmucosal Endoscopic Mucosal Flap Technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years or older, male or female, belonging to any race or ethnic origin
- Patients with manometric positive diagnosis of achalasia, with corresponding symptoms of dysphagia, regurgitation of food or chest pain
- Patients who are willing and competent to sign Informed Consent and to comply with study related visits and procedures
Key exclusion criteria (5 listed)
- Patients who are below 18 years of age
- Presence of coagulopathy
- Pregnancy
- Patients who, in the investigator's opinion, are medically unstable, are unable to give informed consent, or whose risks outweigh the benefits of participating in the study
- Vulnerable subjects: Prisoners, persons with decisional incapacity, and any person who are directly involved in the study, including their immediate family members, and anybody who may have any conflict of interest such as employees of ERBE, USA.
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 |
|---|---|---|
| Submucosal endoscopic myotomy with mucosal flap techniqueAlso: Per Oral Endoscopic Myotomy (POEM), Natural Orifice Transluminal Endoscopic Surgery (NOTES)Submucosal Endoscopy with Mucosal Flap (SEMF) technique involves the following: (1) injecting 0.9 % normal saline solution to create a submucosal cushion, (2) tiny cut is made into the cushion, (3) Balloon will be used to dilate the opening and allow passage of endoscope in the submucosal space, (4) Upon direct visualization of the muscle fibers, the doctor will cut the circular layers of the diseased muscles, and (5) Tiny clips will be used to close the tiny cut made earlier. | Procedure or surgery | Submucosal Endoscopic Mucosal Flap Technique |
| Submucosal Endoscopic Mucosal Flap (SEMF) techniqueAlso: Per Oral Endoscopic Myotomy, Natural Orifice Transluminal Endoscopic Surgery | Procedure or surgery | Submucosal Endoscopic Mucosal Flap Technique |
Primary outcome
Change in Lower esophageal sphincter pressure (LES)
Time frame: at 3 months post endoscopic myotomy
High Resolution Esophageal Manometry will be done at 3 months to measure LES and the result will be compared to baseline or pre-endoscopic myotomy LES pressure.
Change in frequency of dysphagia
Time frame: 4 weeks post procedure
Swallowing difficulty (dysphagia) will be assessed using the Modified Eckhardt Dysphagia Assessment Tool which includes asking the patient how often he/she experiences swallowing difficulty (0 = none, 1 = occasional, 2 = daily, and 3 = every meal. The score will be compared to pre-myotomy score.
Change in frequency of Regurgitation
Time frame: 4 weeks post procedure
Patient will be asked how often he/she brings up swallowed liquid/solid food or regurgitates (0 = none, 1 = occasional, 2 = daily, and 3 = every meal. The score will be compared to the score prior to the procedure.
Change in frequency of chest pain
Time frame: 4 weeks post procedure
The patient will be asked how often he/she experiences chest pain and the frequency (0 = none, 1 = occasional, 2 = daily, and 3 = every meal. The score will be compared to pre-myotomy score.
Presence of perforation
Time frame: During endoscopic myotomy procedure
Presence of perforation that is seen during the endoscopic procedure.
Presence of bleeding
Time frame: During endoscopic myotomy procedure
Occurence of bleeding during the procedure.
Presence of mediastinal emphysema
Time frame: During endoscopic myotomy procedure
Presence of mediastinal emphysema will be recorded.
Presence of Infection
Time frame: 4 weeks post procedure
Presence of infection within the first 4 weeks post myotomy will be recorded.
Development of stricture at the myotomy site.
Time frame: 3 months post procedure
Development of stricture will be assessed by performing an upper endoscopy for patients with change in their Modified Dysphagia Score.
3 secondary outcomes
Presence and frequency of heartburn
Time frame: 4 weeks post procedure
Frequency of use of antacids (PPI, H-2 antagonists)
Time frame: 4 weeks post procedure
Change in patient's weight
Time frame: At 3, 6, 9, and 12 months post 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 11 May 2017.
Related trials for Achalasia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Full-thickness Versus Progressive Myotomy in Peroral Endoscopic Esophageal Myotomy in Achalasia: A Randomized Controlled Trial
Achalasia Cardia, Achalasia
RecruitingPhase 3
PREcision MEDicine In Achalasia (PREMEDIA)
Type I Achalasia, Type II Achalasia
RecruitingObservational study
PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features
RecruitingPhase 4
VZV in the Enteric Nervous System: Pathogenesis and Consequences
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.
Stavros N Stavropoulos, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submucosal endoscopic myotomy with mucosal flap technique and Submucosal Endoscopic Mucosal Flap (SEMF) technique in people with Achalasia and Dysphagia, run by Winthrop University Hospital 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 3 inclusion and 5 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 11 May 2017. 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 Lower esophageal sphincter pressure (LES) (time frame: at 3 months post endoscopic myotomy). The study lists 9 primary outcomes in all. 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 11 May 2017.