Clinical trial NCT06629025: The Clinical Manifestation and Prognosis of Pediatric Esophageal Motility Disorders
Official title: The Clinical Manifestation and Prognosis of Pediatric Esophageal Motility Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Motility Disorders
Keywords: Esophageal achalasia
High-resolution esophageal manometry
Esophageal motility disorders in children
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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: 1. Project name:

   The clinical manifestation and prognosis of pediatric esophageal motility disorders
2. 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.
3. 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
4. Participate in human research/clinical trials:

1. 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

5. 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.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients (0-20 years old) who have been clinically diagnosed with esophageal motility disorders

Exclusion Criteria:

* Exclude the diagnosis of esophageal motility disorders

Primary outcomes:
measure: Treatment success rate of esophageal motility disorders
timeFrame: up to 10 years
measure: Number of Patients with Serious and Non-Serious Adverse Events
timeFrame: up to 4 weeks
measure: Time to Disease Progression
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Children's Hospital
Study officials:
affiliation: 17F, No. 8, Chung-Shan South Rd, Taipei 100, Taiwan
name: Chienting Hsu
role: PRINCIPAL_INVESTIGATOR
References: