Esophageal Varices
Conditions
Keywords
upper endoscopy, biliary atresia
Brief summary
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.
Interventions
DEVICEwired magnetic assisted capsule endoscopy
once
DEVICEesophagogastroduodenoscopy
once
Sponsors
National Taiwan University Hospital
Insight Medical Solutions
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aerosol-generating Amount | 1 day | Aerosol-generating amount were measured using the MET ONE airborne particle counter \[DR-528 Handheld Particle Counter (Met One Instruments, Inc., Grants Pass, OR)\]. The device was placed on a platform at the same horizontal level as the patient lying flat, to capture airborne particles (sizes: 0.3-10 μm).Background environmental values were measured prior to each procedure and subtracted to determine net aerosol generation. Results are expressed as the total number of particles generated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Particles Generated Per Minute | 1 day | The total number of particles of each size divided by examination time to calculate per-minute production; comparison between the two groups. |
| Number of Participants With Esophageal Varices | 1 day | We recorded the number of participants who had esophageal varices after completion of the examination. |
| Number of Participants With Gastric Varices | 1 day | We recorded the number of participants who had gastric varices after completion of the examination. |
| Questionnaire Assessments | 1 day | After the procedure, we assessed the patient's pain level using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates severe pain. We also evaluated the patient's willingness to undergo the same procedure again using a questionnaire scored from 0 to 5, where 0 indicates no willingness and 5 indicates strong willingness to repeat the procedure. |
| Examination Time | 1 day | Examination time is defined as the procedure duration, measured from insertion of the examination device into the participant's mouth to complete removal of the device. |
| Completion Rate | 1 day | Completion rate was defined as the proportion of participants in whom successful examination of each anatomical segment (esophagus, stomach, and duodenum) was achieved.Successful completion for each segment was defined as the device reaching and examining the target segment. |
Countries
Taiwan
Participant flow
Recruitment details
The recruitment period is from August 2023 to February 2025, conducted at the Gastroenterology Clinic of National Taiwan University Children's Hospital.
Baseline characteristics
| Characteristic | — |
|---|---|
| < 19 years of age | 19 Participants |
| Age, Continuous | 17.75 years |
| ALT | 22 IU/mL |
| Ascites | 6 Participants |
| Body height | 155 cm |
| Body weight | 53 kg |
| Conscious sedation | 0 Participants |
| Direct bilirubin | 0.21 mg/dL |
| Hb | 12.45 g/dL |
| Liver cirrhosis | 30 Participants |
| Liver transplantation | 8 Participants |
| Platelet | 104 K/uL |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 12 Participants |
| Splenomegaly | 19 Participants |
| Total bilirubin | 1.14 mg/dL |
| WBC | 5.14 K/uL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
None listed