Viewing Study NCT06629025



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06629025
Status: COMPLETED
Last Update Posted: None
First Post: 2024-10-03

Brief Title: The Clinical Manifestation and Prognosis of Pediatric Esophageal Motility Disorders
Sponsor: None
Organization: None

Study Overview

Official Title: The Clinical Manifestation and Prognosis of Pediatric Esophageal Motility Disorders
Status: COMPLETED
Status Verified Date: 2023-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 201011-20221231 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 researchclinical 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None