Esophageal AchalasiaNCT02999451
Snare-assisted POEM for Treatment of Esophageal Achalasia
A study testing snare-assisted POEM and knife-assisted POEM in people with Esophageal Achalasia, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Achalasia
- What is being tested?
- snare-assisted POEM and knife-assisted POEM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 31 Dec 2019
- 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
- Age between 18-70 years
- Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper endoscopy
- Signed written informed consent
Who cannot join
- ASA class > Ⅲ
- Previous endoscopic or surgical treatment for achalasia
- Esophageal malignancy
- Pregnant
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Safety, Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia
POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. In this trial, investigators plan to use snare to assist POEM procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.
- Conditions
- Esophageal Achalasia
- Being tested
- snare-assisted POEM, knife-assisted POEM
- Keywords
- Peroral endoscopic myotomy, Snare, Endoscopic knife, Esophageal 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.
snare-assisted POEMDevice
POEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation.
- After submucosal injection, an initial 2-cm mucosal incision is made by a snare in the posterior esophageal wall.
- A submucosal tunnel from the esophagus to the gastric cardia is created using a snare.
- Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a snare.
- The mucosal incision is closed with endoclips.
knife-assisted POEMDevice
POEM is performed by using a conventional endoscopic knife.
- After submucosal injection, an initial 2-cm mucosal incision is made by a knife in the posterior esophageal wall.
- A submucosal tunnel from the esophagus to the gastric cardia is created using a knife.
- Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a knife.
- The mucosal incision is closed with endoclips.
| Study group | Role | What they receive |
|---|---|---|
| snare group | Experimental | snare-assisted POEM Receives: Device: snare-assisted POEM |
| conventional group | Active comparator | knife-assisted POEM Receives: Device: knife-assisted POEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rates
Clinical success is defined as a post-POEM Eckardt score ≤3 without additional treatment (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).
Measured: 12 months after treatment
Secondary outcomes (12)
Procedure-related adverse events
Adverse events are defined and graded according to the American Society for Gastrointestinal Endoscopy lexicon (Cotton PB et al, Gastrointest Endosc 2010). Incidental findings of pneumoperitoneum, pneumothorax, pneumomediastinum, pleural effusion on postoperative imaging, and subcutaneous emphysema were documented while not considered as adverse events.
Measured: baseline to 12 months after treatment
Procedure time
Procedure time is measured from the start of submucosal injection until mucosal entry closure.
Measured: POEM procedure
The volume of intraoperative bleeding
Measured: POEM procedure
The use of hemostatic forceps
Measured: POEM procedure
Postoperative pain requiring the use of tramadol
Pain related to POEM procedure requiring the use of tramadol pain medication.
Measured: Through hospital stay after procedure, an average of 2-7 days
The length of postoperative hospital stay
Measured: Through hospital stay after procedure, an average of 2-7 daysc
Total hospital costs of treatment per participants
Measured: Through hospital stay after procedure, an average of 2-7 days
Eckardt score
The Eckardt score assesses the severity of achalasia symptoms by combining the sum of symptom frequency scores for dysphagia, regurgitation, and chest pain and a weight loss score. Each component can be graded from 0 to 3 points. The total range is 0 to 12, with higher scores indicating more severe symptoms (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).
Measured: baseline, 3 months and 12 months after treatment
Manometry parameters
Manometry parameters include lower esophageal sphincter (LES) pressure and integrated relaxation pressure (IRP) on high resolution manometry.
Measured: baseline and 3 months after treatment
Maximum esophageal diameter on barium esophagram
Measured: baseline and 3 months after treatment
Gastroesophageal reflux disease questionnaire (GerdQ) score
The GerdQ has been developed as a tool to facilitate the symptom-based diagnosis of GERD. Scores ranging from 0 to 3 were applied for the four positive predictors (heartburn, regurgitation, sleep disturbance due to reflux symptoms and use of over-the-counter medications for reflux symptoms) and from 3 to 0 for two negative predictors (epigastric pain and nausea). The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. A total GerdQ score >7 is considered indicative of significant GERD symptoms (Jones R et al, Aliment Pharmacol Ther 2009).
Measured: baseline, 3 months and 12 months after treatment
Reflux esophagitis on post-POEM endoscopy
The severity of reflux esophagitis is graded according to the Los Angeles classification (Armstrong D et al, Gastroenterology 1996).
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start1 May 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AchalasiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangbin Xing, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xiangbin Xing, MD, PhD, Study director, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999451
- Sponsor's protocol ID
- 123
- Status last verified
- Jun 2020
- First submitted
- 29 Nov 2016
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia
- ClinicalTrials.gov ID
- NCT02999451
- Acronym / sponsor ID
- 123
- Conditions
- Esophageal Achalasia
- Keywords
- Peroral endoscopic myotomy, Snare, Endoscopic knife, Esophageal Achalasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Dec 2016 (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.
POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. In this trial, investigators plan to use snare to assist POEM procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| snare group | Experimental | Device: snare-assisted POEMsnare-assisted POEM |
| conventional group | Active comparator | Device: knife-assisted POEMknife-assisted POEM |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18-70 years
- Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper endoscopy
- Signed written informed consent
Key exclusion criteria (4 listed)
- ASA class > Ⅲ
- Previous endoscopic or surgical treatment for achalasia
- Esophageal malignancy
- Pregnant
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 |
|---|---|---|
| snare-assisted POEMPOEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation. 1. After submucosal injection, an initial 2-cm mucosal incision is made by a snare in the posterior esophageal wall. 2. A submucosal tunnel from the esophagus to the gastric cardia is created using a snare. 3. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a snare. 4. The mucosal incision is closed with endoclips. | Device | snare group |
| knife-assisted POEMPOEM is performed by using a conventional endoscopic knife. 1. After submucosal injection, an initial 2-cm mucosal incision is made by a knife in the posterior esophageal wall. 2. A submucosal tunnel from the esophagus to the gastric cardia is created using a knife. 3. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a knife. 4. The mucosal incision is closed with endoclips. | Device | conventional group |
Primary outcome
Clinical success rates
Time frame: 12 months after treatment
Clinical success is defined as a post-POEM Eckardt score ≤3 without additional treatment (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).
12 secondary outcomes
Procedure-related adverse events
Time frame: baseline to 12 months after treatment
Procedure time
Time frame: POEM procedure
The volume of intraoperative bleeding
Time frame: POEM procedure
The use of hemostatic forceps
Time frame: POEM procedure
Postoperative pain requiring the use of tramadol
Time frame: Through hospital stay after procedure, an average of 2-7 days
The length of postoperative hospital stay
Time frame: Through hospital stay after procedure, an average of 2-7 daysc
Total hospital costs of treatment per participants
Time frame: Through hospital stay after procedure, an average of 2-7 days
Eckardt score
Time frame: baseline, 3 months and 12 months after treatment
Manometry parameters
Time frame: baseline and 3 months after treatment
Maximum esophageal diameter on barium esophagram
Time frame: baseline and 3 months after treatment
Gastroesophageal reflux disease questionnaire (GerdQ) score
Time frame: baseline, 3 months and 12 months after treatment
Reflux esophagitis on post-POEM endoscopy
Time frame: 3 months after treatment
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 30 Jun 2020.
- 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.
Xiangbin Xing, MD, PhD study director
First Affiliated Hospital, Sun Yat-Sen 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 snare-assisted POEM and knife-assisted POEM in people with Esophageal Achalasia, run by First Affiliated Hospital, Sun Yat-Sen 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 3 inclusion and 4 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 30 Jun 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 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?
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?
Clinical success rates (time frame: 12 months after treatment). 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 30 Jun 2020.