Esophageal AchalasiaNCT03012854
Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia
A study testing short-myotomy, long-myotomy and full-thickness myotomy in people with Esophageal Achalasia and Esophageal Motility Disorders, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This study compares the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Achalasia, Esophageal Motility Disorders
- What is being tested?
- short-myotomy, long-myotomy and full-thickness myotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 75 years of age;
- Patient with esophageal achalasia;
- Eckardt score > 3;
- Signed informed consent.
Who cannot join
- Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk;
- Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in the distal oesophagus;
- Previous endoscopic Botox injection;
- Previous oesophageal or gastric surgery;
- Pregnancy or lactation women, or ready to pregnant women;
- Not capable of filling out questionnaires.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guanzhou, Guangdong, 510515
Wei Gong, Doctor, 86-15820290385, drgwei@foxmail.com
Silin Huang, Master, 86-13512756686, 13816757@qq.com
About this study
Official title: Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia: a Multicenter Prospective Randomized Controlled Trial
This study compares the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.
Read the detailed description
Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food.
Currently, treatment options mainly focus on relief of the symptoms by reducing the LES pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia. However, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM) combined with Dor's antireflux procedure has gained considerable interest. The LHM can sustain therapeutic effects for long-term in approximately 80% of patients.
Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically, POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction.
However, the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients were not determined, and there was no prospective study that compared different surgical procedures of POEM for esophageal achalasia. Therefore, we aim to compare the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.
- Being tested
- short-myotomy, long-myotomy, full-thickness myotomy, circular myotomy
- Keywords
- Esophageal achalasia, Peroral endoscopic myotomy, POEM
- Medical subject headings
- Esophageal Achalasia, Esophageal Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short-myotomyProcedure or surgery
- Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
- Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
- Endoscopic myotomy is carried out in a proximal to distal direction to a total length less than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
- Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
- Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
long-myotomyProcedure or surgery
- Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
- Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
- Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
- Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
- Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
full-thickness myotomyProcedure or surgery
- Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
- Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
- Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
- Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
- Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
circular myotomyProcedure or surgery
- Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
- Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
- Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
- Myotomy of inner circular muscle bundles is done, leaving the outer longitudinal muscle layer intact.
- Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
| Study group | Role | What they receive |
|---|---|---|
| short-myotomy | Experimental | Short-POEM for patients with esophageal achalasia Receives: Procedure: short-myotomy |
| long-myotomy | Active comparator | Long-POEM for patients with esophageal achalasia Receives: Procedure: long-myotomy |
| full-thickness myotomy | Experimental | Full-thickness-POEM for patients with esophageal achalasia Receives: Procedure: full-thickness myotomy |
| circular myotomy | Active comparator | Circular-POEM for patients with esophageal achalasia Receives: Procedure: circular myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic success
Therapeutic success is defined as a symptom control to an Eckardt score of 3 or less. The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of <5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of >10 kg) (Eckardt, V. Gastroenterology, 1992. 103(6): p. 1732-8.)
Measured: From date of randomization until the follow-up ended, assessed up to 5 years
Secondary outcomes (4)
Procedure related complication
Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak etc.
Measured: From date of randomization until the follow-up ended, assessed up to 5 years
Time of treatment failure
Time of treatment failure is defined as when the Eckardt score of patients are more than 3.
Measured: From date of randomization until the follow-up ended, assessed up to 5 years
Pressure at the lower esophageal sphincter
From date of randomization until the follow-up ended, assessed up to 5 years
Measured: From date of randomization until the follow-up ended, assessed up to 5 years
Quality of life
Patients will complete the quality-of-life questionnaires (the Medical Outcomes Study 36-Item Short-Form Health Survey, SF-36) for assessing quality of life.
Measured: From date of randomization until the follow-up ended, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal AchalasiaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Gong, Nanfang Hospital, Southern Medical University
- Investigators
- Wei Gong, Doctor, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012854
- Sponsor's protocol ID
- NFEC-2016-186
- Status last verified
- May 2017
- First submitted
- 5 Jan 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
PubMed 20354937Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR; European Achalasia Trial Investigators. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med. 2011 May 12;364(19):1807-16. doi: 10.1056/NEJMoa1010502.
PubMed 21561346
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia: a Multicenter Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03012854
- Acronym / sponsor ID
- NFEC-2016-186
- Keywords
- Esophageal achalasia, Peroral endoscopic myotomy, POEM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Jan 2017 (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 compares the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.
Detailed description
Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food.
Currently, treatment options mainly focus on relief of the symptoms by reducing the LES pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia. However, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM) combined with Dor's antireflux procedure has gained considerable interest. The LHM can sustain therapeutic effects for long-term in approximately 80% of patients.
Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically, POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction.
However, the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients were not determined, and there was no prospective study that compared different surgical procedures of POEM for esophageal achalasia. Therefore, we aim to compare the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| short-myotomy | Experimental | Procedure: short-myotomyShort-POEM for patients with esophageal achalasia |
| long-myotomy | Active comparator | Procedure: long-myotomyLong-POEM for patients with esophageal achalasia |
| full-thickness myotomy | Experimental | Procedure: full-thickness myotomyFull-thickness-POEM for patients with esophageal achalasia |
| circular myotomy | Active comparator | Procedure: circular myotomyCircular-POEM for patients with esophageal achalasia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18 and 75 years of age;
- Patient with esophageal achalasia;
- Eckardt score > 3;
- Signed informed consent.
Key exclusion criteria (6 listed)
- Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk;
- Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in the distal oesophagus;
- Previous endoscopic Botox injection;
- Previous oesophageal or gastric surgery;
- Pregnancy or lactation women, or ready to pregnant women;
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 |
|---|---|---|
| short-myotomy1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ. 3. Endoscopic myotomy is carried out in a proximal to distal direction to a total length less than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ. 4. Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done. 5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips. | Procedure or surgery | short-myotomy |
| long-myotomy1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ. 3. Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ. 4. Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done. 5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips. | Procedure or surgery | long-myotomy |
| full-thickness myotomy1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ. 3. Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ. 4. Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done. 5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips. | Procedure or surgery | full-thickness myotomy |
| circular myotomy1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ. 3. Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ. 4. Myotomy of inner circular muscle bundles is done, leaving the outer longitudinal muscle layer intact. 5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips. | Procedure or surgery | circular myotomy |
Primary outcome
Therapeutic success
Time frame: From date of randomization until the follow-up ended, assessed up to 5 years
Therapeutic success is defined as a symptom control to an Eckardt score of 3 or less. The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of <5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of >10 kg) (Eckardt, V. Gastroenterology, 1992. 103(6): p. 1732-8.)
4 secondary outcomes
Procedure related complication
Time frame: From date of randomization until the follow-up ended, assessed up to 5 years
Time of treatment failure
Time frame: From date of randomization until the follow-up ended, assessed up to 5 years
Pressure at the lower esophageal sphincter
Time frame: From date of randomization until the follow-up ended, assessed up to 5 years
Quality of life
Time frame: From date of randomization until the follow-up ended, assessed up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Background: PubMed 20354937Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
- Background: PubMed 21561346Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR; European Achalasia Trial Investigators. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med. 2011 May 12;364(19):1807-16. doi: 10.1056/NEJMoa1010502.
- Homepage of Nanfang Hospital of Southern Medical UniversityLink provided by the sponsor.
- Homepage of Department of Gastroenterology, Nanfang Hospital of Southern Medical UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Wei Gong, Doctor principal investigator
Nanfang Hospital, Southern Medical 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 short-myotomy, long-myotomy and full-thickness myotomy in people with Esophageal Achalasia and Esophageal Motility Disorders, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 12 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Gong, Doctor (86-15820290385, drgwei@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic success (time frame: From date of randomization until the follow-up ended, assessed up to 5 years). 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 NCT03012854, which also lists 2 linked publications.
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 12 May 2017.