Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

National Taiwan University

Status

Completed

Conditions

Esophageal Varices

Treatments

Device: esophagogastroduodenoscopy

Device: wired magnetic assisted capsule endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT06017102

202210059DIPA

Details and patient eligibility

About

The goal of this clinical trial is to compare the safeness and effectiveness of traditional esophagogastroduodenoscope (EGD) and wired magnetically assisted capsule endoscopy (MACE) in the diagnosis of esophageal varices in biliary atresia (BA) patients. The main questions it aims to answer are:

Subjects who do wired magnetically assisted capsule endoscopy do not need to open the mouths during the process, this study also want to know whether wired magnetically assisted capsule endoscopy can reduce the generation of droplets.
Diagnostic accuracy between traditional esophagogastroduodenoscope and wired magnetically assisted capsule endoscopy in biliary atresia patients with esophageal varices.

Participants will do either traditional esophagogastroduodenoscope or wired magnetically assisted capsule endoscopy.

Enrollment

50 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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