NCT06629025

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

October 3, 2024

Last Update Submit

October 3, 2024

Conditions

Keywords

Esophageal achalasiaHigh-resolution esophageal manometryEsophageal motility disorders in children

Outcome Measures

Primary Outcomes (3)

  • Treatment success rate of esophageal motility disorders

    up to 10 years

  • Number of Patients with Serious and Non-Serious Adverse Events

    up to 4 weeks

  • Time to Disease Progression

    up to 10 years

Study Arms (1)

esophageal motility disorder

Pediatric patients (0-20 years old) with clinically diagnosed abnormal esophageal motility

Diagnostic Test: High-resolution impedance manometry

Interventions

High-resolution impedance manometry (HRIM) can calculate the bolus motion parameters and the ratio of complete esophageal transit

Also known as: Peroral endoscopic myotomy (POEM)
esophageal motility disorder

Eligibility Criteria

Age0 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Exclude the diagnosis of esophageal motility disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Children's Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Esophageal Motility DisordersEsophageal Achalasia

Condition Hierarchy (Ancestors)

Deglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Chienting Hsu

    17F, No. 8, Chung-Shan South Rd, Taipei 100, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 8, 2024

Study Start

March 15, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

October 8, 2024

Record last verified: 2023-03

Locations