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临床试验/NCT06629025
NCT06629025已完成不适用

The Clinical Manifestation and Prognosis of Pediatric Esophageal Motility Disorders

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Treatment success rate of esophageal motility disorders

研究概览

简要总结

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

详细描述

  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

  2. 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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
0 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Exclude the diagnosis of esophageal motility disorders

结局指标

主要结局

Treatment success rate of esophageal motility disorders

时间窗: up to 10 years

Number of Patients with Serious and Non-Serious Adverse Events

时间窗: up to 4 weeks

Time to Disease Progression

时间窗: up to 10 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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