Esophageal AchalasiaNCT05010889
Quality of Life After POEM for Achalasia
An observational study of Esophageal Achalasia, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Achalasia is an esophageal motility disorder, characterized by insufficient lower esophageal sphincter relaxation and loss of esophageal peristalsis. Patients with achalasia experience distressing gastrointestinal symptoms, including dysphagia, reflux and chest pain, which lead to weight loss and malnutrition. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Achalasia
- What is being tested?
- Peroral endoscopic myotomy (POEM)
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients schedule to undergo POEM for treatment of symptomatic achalasia in one tertiary hospital.
Who may be able to join
- Diagnosed as achalasia base on high resolution manometry, barium esophagram and upper endoscopy
- Scheduled to undergo POEM for treatment of achalasia
Who cannot join
- Coagulopathy and systemic disorders that precluded safe general anesthesia
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: Health-Related Quality of Life After Peroral Endoscopic Myotomy for Patients With Achalasia
Achalasia is an esophageal motility disorder, characterized by insufficient lower esophageal sphincter relaxation and loss of esophageal peristalsis. Patients with achalasia experience distressing gastrointestinal symptoms, including dysphagia, reflux and chest pain, which lead to weight loss and malnutrition. Undoubtedly, health-related quality of life can be significantly diminished in patients with achalasia. At present, POEM has become one of the standard therapies for achalasia. Limited studies have focused on the patient's quality of life before and after POEM. The present study aimed to assess the changes in quality of life of patients with achalasia using the validated achalasia severity questionnaire (ASQ) and the short form (SF)-36 scale.
- Conditions
- Esophageal Achalasia
- Being tested
- Peroral endoscopic myotomy (POEM)
- Keywords
- Esophageal Achalasia, Peroral Endoscopic Myotomy, Quality of Life
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroral endoscopic myotomy (POEM)Procedure or surgery
POEM is performed as previously described by Inoue et al (Endoscopy 2010), including four main steps mucosal incision, submucosal tunneling, myotomy and mucosal entry closure.
| Study group | Role | What they receive |
|---|---|---|
| Achalasia patients | Patients schedule to undergo POEM for treatment of symptomatic achalasia. The diagnosis of achalasia was based on high resolution manometry, barium esophagram, and upper endoscopy. Receives: Procedure: Peroral endoscopic myotomy (POEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achalasia symptom questionnaire (ASQ)
Achalasia symptom questionnaire assess the disease-specific health-related quality of life by sampling the concepts of food tolerance, dysphagia-related behavior modifications, pain, heartburn, distress, lifestyle limitation, and satisfaction in 10 items. The total range is 10 to 31, with higher scores indicating worse quality of life (Urbach et al, Am J Gastroenterol 2005).
Measured: Baseline, Change from Baseline ASQ score at 3 months and 12 months after treatment
Short form (SF)-36
The short form (SF)-36 (best score 100, worst score 0). The short form (SF)-36 assess the health-related quality of life from 8 aspects, including physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health in 36 items. The total range is 0 to 100, with lower scores indicating worse quality of life (Ware et al, J Clin Epidemiol 1998).
Measured: Baseline, Change from Baseline SF-36 score at 3 months and 12 months after treatment
Secondary outcomes (3)
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
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 posted18 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
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
- NCT05010889
- Sponsor's protocol ID
- 124
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 18 Aug 2021
- 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 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life After Peroral Endoscopic Myotomy for Patients With Achalasia
- ClinicalTrials.gov ID
- NCT05010889
- Acronym / sponsor ID
- 124
- Conditions
- Esophageal Achalasia
- Keywords
- Esophageal Achalasia, Peroral Endoscopic Myotomy, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Aug 2021 (actual)
- 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.
Achalasia is an esophageal motility disorder, characterized by insufficient lower esophageal sphincter relaxation and loss of esophageal peristalsis. Patients with achalasia experience distressing gastrointestinal symptoms, including dysphagia, reflux and chest pain, which lead to weight loss and malnutrition. Undoubtedly, health-related quality of life can be significantly diminished in patients with achalasia. At present, POEM has become one of the standard therapies for achalasia. Limited studies have focused on the patient's quality of life before and after POEM. The present study aimed to assess the changes in quality of life of patients with achalasia using the validated achalasia severity questionnaire (ASQ) and the short form (SF)-36 scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Achalasia patients | – | Procedure: Peroral endoscopic myotomy (POEM)Patients schedule to undergo POEM for treatment of symptomatic achalasia. The diagnosis of achalasia was based on high resolution manometry, barium esophagram, and upper endoscopy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients schedule to undergo POEM for treatment of symptomatic achalasia in one tertiary hospital.
Key inclusion criteria (2 listed)
- Diagnosed as achalasia base on high resolution manometry, barium esophagram and upper endoscopy
- Scheduled to undergo POEM for treatment of achalasia
Key exclusion criteria (1 listed)
- Coagulopathy and systemic disorders that precluded safe general anesthesia
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 |
|---|---|---|
| Peroral endoscopic myotomy (POEM)POEM is performed as previously described by Inoue et al (Endoscopy 2010), including four main steps mucosal incision, submucosal tunneling, myotomy and mucosal entry closure. | Procedure or surgery | Achalasia patients |
Primary outcome
Achalasia symptom questionnaire (ASQ)
Time frame: Baseline, Change from Baseline ASQ score at 3 months and 12 months after treatment
Achalasia symptom questionnaire assess the disease-specific health-related quality of life by sampling the concepts of food tolerance, dysphagia-related behavior modifications, pain, heartburn, distress, lifestyle limitation, and satisfaction in 10 items. The total range is 10 to 31, with higher scores indicating worse quality of life (Urbach et al, Am J Gastroenterol 2005).
Short form (SF)-36
Time frame: Baseline, Change from Baseline SF-36 score at 3 months and 12 months after treatment
The short form (SF)-36 (best score 100, worst score 0). The short form (SF)-36 assess the health-related quality of life from 8 aspects, including physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health in 36 items. The total range is 0 to 100, with lower scores indicating worse quality of life (Ware et al, J Clin Epidemiol 1998).
3 secondary outcomes
Eckardt score
Time frame: baseline, 3 months and 12 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- 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?
An observational study of 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 2 inclusion and 1 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 18 Aug 2021. 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 Xiangbin Xing, MD, PhD (+862087755766, xxbken@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achalasia symptom questionnaire (ASQ) (time frame: Baseline, Change from Baseline ASQ score at 3 months and 12 months after treatment). The study lists 2 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 18 Aug 2021.