Esophageal Motility DisordersNCT06629025
The Clinical Manifestation and Prognosis of Pediatric Esophageal Motility Disorders
An observational study of Esophageal Motility Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background: Abnormal esophageal peristalsis mostly occurs in adults, but some patients have onset in childhood. Most of the symptoms of esophageal motility disorders in children are not as clear as those described by adult patients, and they are only manifested in repeated vomiting. Read more about this study
- Who is it for?
- Ages 0 to 20 years
- Conditions the study is for
- Esophageal Motility Disorders
- What is being tested?
- High-resolution impedance manometry
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2023to 5 Feb 2024
- 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 0 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: We plan to collect pediatric patients (0-20 years old) diagnosed with esophageal motility disorders at National Taiwan University Hospital during 2010/1/1-2022/12/31.
Who may be able to join
- Pediatric patients (0-20 years old) who have been clinically diagnosed with esophageal motility disorders
Who cannot join
- Exclude the diagnosis of esophageal motility disorders
Trial locations and contacts
1 site in 1 country.
About this study
Background: Abnormal esophageal peristalsis mostly occurs in adults, but some patients have onset in childhood. Most of the symptoms of esophageal motility disorders in children are not as clear as those described by adult patients, and they are only manifested in repeated vomiting. Esophageal peristalsis abnormalities in children took longer from symptoms to diagnosis than in adults. Common esophageal motility disorders in children include Achalasia, ineffective esophageal motility disorder (IEM), absent contractility, nutcracker esophagus, jackhammer esophagus, diffuse Esophageal spasm (diffuse esophageal spasm), lower esophageal sphincter hypertension (hypertensive lower esophageal sphincter), etc. Treatment for abnormal esophageal motility includes medication, endoscopic therapy, and surgery. This includes peroral endoscopic myotomy (POEM). The above treatment effects are rarely reported in children. This project uses the method of retrospective analysis of medical records to study the clinical manifestations and treatment prognosis of abnormal esophageal motility in children
Research purpose: The purpose of this study is to evaluate various clinical manifestations and treatment prognosis of abnormal esophageal motility in children, including analysis of diagnosis age, symptom time, related imaging examinations, endoscopy and high-resolution esophageal pressure examination, treatment methods, etc.
Read more
Research design: We plan to collect pediatric patients (0-20 years old) diagnosed with abnormal esophageal peristalsis at National Taiwan University Hospital during 2010/1/1-2022/12/31. Retrospective analysis of medical records and relevant laboratory data of patients in hospitals, including gender, height and weight, age of onset, symptoms, clinical manifestations, endoscopy, gastrointestinal photography, 24-hour multi-lumen esophageal impedance and acid-base examination, high-resolution esophageal pressure examination, ultrasound examination, pathological slide report, treatment response, etc.
Expected results: Analyze the clinical symptoms and different treatment methods of abnormal esophageal motility in children, and understand the development and prognosis of abnormal esophageal motility in children.
Key words: Esophageal motility disorders in children; High-resolution esophageal manometry; Esophageal achalasia
Read the detailed description
- Project name: The clinical manifestation and prognosis of pediatric esophageal motility disorders
- Research purposes: The purpose of this study is to evaluate various clinical manifestations and treatment prognosis of esophageal motility disorders in children, including analysis of diagnosis age, symptom time, relevant imaging examinations, endoscopy and high-resolution esophageal pressure examination, treatment methods, etc.
- Research background esophageal motility disorders occurs in adults, but there are still some patients with onset in childhood. Most of the symptoms of esophageal motility disorders in children are not as clear as those described by adult patients, and they are only manifested in repeated vomiting. Esophageal peristalsis abnormalities in children took longer from symptoms to diagnosis than in adults. Common esophageal motility disorders in children include Achalasia, ineffective esophageal motility disorder (IEM), absent contractility, nutcracker esophagus, jackhammer esophagus, diffuse Esophageal spasm (diffuse esophageal spasm), lower esophageal sphincter hypertension (hypertensive lower esophageal sphincter), etc. Treatment for abnormal esophageal motility includes medication, endoscopic therapy, and surgery. This includes peroral endoscopic myotomy (POEM). The above treatment effects are rarely reported in children. This project uses the method of retrospective analysis of medical records to study the clinical manifestations and treatment prognosis of abnormal esophageal motility in children
- Participate in human research/clinical trials:
- Main inclusion criteria: Pediatric patients (0-20 years old) who have been clinically diagnosed with abnormal esophageal motility 2. Main exclusion criteria: Exclude the diagnosis of abnormal esophageal motility
- Research Design Pediatric patients (0-20 years old) who were diagnosed with esophageal motility disorders at National Taiwan University Hospital between January 1, 2010 and December 31, 2022. The medical records and relevant laboratory data of the patients at National Taiwan University Hospital were retrospectively analyzed, including Gender, height and weight, age of onset, symptoms, clinical manifestations, endoscopic examination, gastrointestinal photography, 24-hour multi-lumen esophageal impedance and acid-base examination, high-resolution esophageal pressure examination, ultrasound examination, pathological slide report, treatment response wait. During the data collection process, relevant medical records are stored in the Gastroenterology Laboratory of the Pediatric Department of National Taiwan University Hospital, which is locked. The computers and servers that store the data are protected by passwords. The data will be stored and analyzed in the hospital. Personal information that can be identified will be protected by code or file encryption. The host personally confirms that all researchers (including the host) have completed the training on medical record privacy protection and information security, and signed the conclusion of the confidentiality statement. When all the data is collected and analyzed, the moderator will completely de-identify the data.
- Conditions
- Esophageal Motility Disorders
- Being tested
- High-resolution impedance manometry
- Keywords
- Esophageal achalasia, High-resolution esophageal manometry, Esophageal motility disorders in children
- Medical subject headings
- Esophageal Motility Disorders, Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-resolution impedance manometryDiagnostic test
Also called Peroral endoscopic myotomy (POEM)
High-resolution impedance manometry (HRIM) can calculate the bolus motion parameters and the ratio of complete esophageal transit
| Study group | Role | What they receive |
|---|---|---|
| esophageal motility disorder | Pediatric patients (0-20 years old) with clinically diagnosed abnormal esophageal motility Receives: Diagnostic Test: High-resolution impedance manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success rate of esophageal motility disorders
Measured: up to 10 years
Number of Patients with Serious and Non-Serious Adverse Events
Measured: up to 4 weeks
Time to Disease Progression
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Mar 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Motility DisordersStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chienting Hsu, Principal investigator, 17F, No. 8, Chung-Shan South Rd, Taipei 100, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629025
- Sponsor's protocol ID
- 202302017RIND
- Status last verified
- Mar 2023
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Manifestation and Prognosis of Pediatric Esophageal Motility Disorders
- ClinicalTrials.gov ID
- NCT06629025
- Acronym / sponsor ID
- 202302017RIND
- Conditions
- Esophageal Motility Disorders
- Keywords
- Esophageal achalasia, High-resolution esophageal manometry, Esophageal motility disorders in children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 8 Oct 2024 (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.
Background: Abnormal esophageal peristalsis mostly occurs in adults, but some patients have onset in childhood. Most of the symptoms of esophageal motility disorders in children are not as clear as those described by adult patients, and they are only manifested in repeated vomiting. Esophageal peristalsis abnormalities in children took longer from symptoms to diagnosis than in adults. Common esophageal motility disorders in children include Achalasia, ineffective esophageal motility disorder (IEM), absent contractility, nutcracker esophagus, jackhammer esophagus, diffuse Esophageal spasm (diffuse esophageal spasm), lower esophageal sphincter hypertension (hypertensive lower esophageal sphincter), etc. Treatment for abnormal esophageal motility includes medication, endoscopic therapy, and surgery. This includes peroral endoscopic myotomy (POEM). The above treatment effects are rarely reported in children. This project uses the method of retrospective analysis of medical records to study the clinical manifestations and treatment prognosis of abnormal esophageal motility in children
Research purpose: The purpose of this study is to evaluate various clinical manifestations and treatment prognosis of abnormal esophageal motility in children, including analysis of diagnosis age, symptom time, related imaging examinations, endoscopy and high-resolution esophageal pressure examination, treatment methods, etc.
Research design: We plan to collect pediatric patients (0-20 years old) diagnosed with abnormal esophageal peristalsis at National Taiwan University Hospital during 2010/1/1-2022/12/31. Retrospective analysis of medical records and relevant laboratory data of patients in hospitals, including gender, height and weight, age of onset, symptoms, clinical manifestations, endoscopy, gastrointestinal photography, 24-hour multi-lumen esophageal impedance and acid-base examination, high-resolution esophageal pressure examination, ultrasound examination, pathological slide report, treatment response, etc.
Expected results: Analyze the clinical symptoms and different treatment methods of abnormal esophageal motility in children, and understand the development and prognosis of abnormal esophageal motility in children.
Key words: Esophageal motility disorders in children; High-resolution esophageal manometry; Esophageal achalasia
Detailed description
- Project name: The clinical manifestation and prognosis of pediatric esophageal motility disorders
- Research purposes: The purpose of this study is to evaluate various clinical manifestations and treatment prognosis of esophageal motility disorders in children, including analysis of diagnosis age, symptom time, relevant imaging examinations, endoscopy and high-resolution esophageal pressure examination, treatment methods, etc.
- Research background esophageal motility disorders occurs in adults, but there are still some patients with onset in childhood. Most of the symptoms of esophageal motility disorders in children are not as clear as those described by adult patients, and they are only manifested in repeated vomiting. Esophageal peristalsis abnormalities in children took longer from symptoms to diagnosis than in adults. Common esophageal motility disorders in children include Achalasia, ineffective esophageal motility disorder (IEM), absent contractility, nutcracker esophagus, jackhammer esophagus, diffuse Esophageal spasm (diffuse esophageal spasm), lower esophageal sphincter hypertension (hypertensive lower esophageal sphincter), etc. Treatment for abnormal esophageal motility includes medication, endoscopic therapy, and surgery. This includes peroral endoscopic myotomy (POEM). The above treatment effects are rarely reported in children. This project uses the method of retrospective analysis of medical records to study the clinical manifestations and treatment prognosis of abnormal esophageal motility in children
- Participate in human research/clinical trials:
- Main inclusion criteria: Pediatric patients (0-20 years old) who have been clinically diagnosed with abnormal esophageal motility 2. Main exclusion criteria: Exclude the diagnosis of abnormal esophageal motility
- Research Design Pediatric patients (0-20 years old) who were diagnosed with esophageal motility disorders at National Taiwan University Hospital between January 1, 2010 and December 31, 2022. The medical records and relevant laboratory data of the patients at National Taiwan University Hospital were retrospectively analyzed, including Gender, height and weight, age of onset, symptoms, clinical manifestations, endoscopic examination, gastrointestinal photography, 24-hour multi-lumen esophageal impedance and acid-base examination, high-resolution esophageal pressure examination, ultrasound examination, pathological slide report, treatment response wait. During the data collection process, relevant medical records are stored in the Gastroenterology Laboratory of the Pediatric Department of National Taiwan University Hospital, which is locked. The computers and servers that store the data are protected by passwords. The data will be stored and analyzed in the hospital. Personal information that can be identified will be protected by code or file encryption. The host personally confirms that all researchers (including the host) have completed the training on medical record privacy protection and information security, and signed the conclusion of the confidentiality statement. When all the data is collected and analyzed, the moderator will completely de-identify the data.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| esophageal motility disorder | – | Diagnostic Test: High-resolution impedance manometryPediatric patients (0-20 years old) with clinically diagnosed abnormal esophageal motility |
Who may qualify
- Ages
- 0 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We plan to collect pediatric patients (0-20 years old) diagnosed with esophageal motility disorders at National Taiwan University Hospital during 2010/1/1-2022/12/31.
Key inclusion criteria (1 listed)
- Pediatric patients (0-20 years old) who have been clinically diagnosed with esophageal motility disorders
Key exclusion criteria (1 listed)
- Exclude the diagnosis of esophageal motility disorders
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 |
|---|---|---|
| High-resolution impedance manometryAlso: Peroral endoscopic myotomy (POEM)High-resolution impedance manometry (HRIM) can calculate the bolus motion parameters and the ratio of complete esophageal transit | Diagnostic test | esophageal motility disorder |
Primary outcome
Treatment success rate of esophageal motility disorders
Time frame: up to 10 years
Number of Patients with Serious and Non-Serious Adverse Events
Time frame: up to 4 weeks
Time to Disease Progression
Time frame: up to 10 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 8 Oct 2024.
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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.
Chienting Hsu principal investigator
17F, No. 8, Chung-Shan South Rd, Taipei 100, Taiwan
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 Motility Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: finished, as of the sponsor's last update on 8 Oct 2024. 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 Taiwan. 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?
Treatment success rate of esophageal motility disorders (time frame: up to 10 years). The study lists 3 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 8 Oct 2024.