Comparing two methods for diagnosing esophageal varices in biliary atresia patients
Difference in Aerosol-generating Amount Between Wired Magnetic-assisted Capsule Endoscopy System and Esophagogastroduodenoscopy Examination of Varices in Biliary Atresia Patients
This study is testing if a new method using a magnetically assisted capsule can safely and effectively diagnose esophageal varices in patients with biliary atresia, compared to the traditional endoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei City) |
| Trial ID | NCT06017102 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of wired magnetically assisted capsule endoscopy (MACE) compared to traditional esophagogastroduodenoscopy (EGD) for diagnosing esophageal varices in patients with biliary atresia. Participants will undergo either MACE or EGD, with a focus on assessing diagnostic accuracy and the potential reduction of droplet generation during the procedure. The study seeks to determine if MACE can provide a less invasive alternative for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are biliary atresia patients over 6 years old who are stable and do not have acute gastrointestinal bleeding.
Not a fit: Patients with metal implants, electronic devices, or those experiencing acute upper gastrointestinal bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer and more comfortable diagnostic option for patients with biliary atresia and esophageal varices.
How similar studies have performed: While traditional methods have been widely used, the approach of using wired magnetically assisted capsule endoscopy is relatively novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biliary atresia patients \> 6 years old * Vital signs are stable * Without acute gastrointestinal bleeding Exclusion Criteria: * Patients with metal implants, metal stent, artificial joints, bone plates, and bone screw * Patients with electronic devices, such as pacemakers, cochlear implants, or other implanted electronic medical devices * Throat or esophageal obstruction leading to dysphagia patients * Consciousness disturbance patients unable to swallow * Patients with acute upper gastrointestinal bleeding * Patients with platelet lower than 40K or PT INR \> 1.5
Where this trial is running
Taipei City
- National Taiwan University Hospital — Taipei City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Jia-Feng Wu, PhD
- Email: wjf@ntu.edu.tw
- Phone: +886 23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.