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| Name | Class |
|---|---|
| Insight Medical Solutions | UNKNOWN |
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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:
Participants will do either traditional esophagogastroduodenoscope or wired magnetically assisted capsule endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wired magnetic assisted capsule endoscopy | Experimental |
| |
| esophagogastroduodenoscopy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wired magnetic assisted capsule endoscopy | Device | once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Aerosol-generating Amount | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Particles Generated Per Minute | The total number of particles of each size divided by examination time to calculate per-minute production; comparison between the two groups. | 1 day |
| Number of Participants With Esophageal Varices |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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The recruitment period is from August 2023 to February 2025, conducted at the Gastroenterology Clinic of National Taiwan University Children's Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wired Magnetic Assisted Capsule Endoscopy | This prospective open-label trial enrolls 25 patients aged 6 or older with biliary atresia to undergo wired magnetic-assisted capsule endoscopy (MCE) for esophageal varices, based on the patient's or family's choice. |
| FG001 | Esophagogastroduodenoscopy | Additionally, 25 patients aged 6 years or older with biliary atresia will undergo esophagogastroduodenoscopy for esophageal varices assessment as the control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All 50 participants completed the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Wired Magnetic Assisted Capsule Endoscopy | Participants in this group undergo wired magnetic-assisted capsule endoscopy to assess esophageal varices, which is a non-invasive method decided based on the patient's or family's choice. |
| BG001 | Esophagogastroduodenoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aerosol-generating Amount | 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. | All 50 participants completed the trial. | Posted | Median | Inter-Quartile Range | Particles generated | 1 day |
|
Adverse event data were collected on the day of the examination, up to 1 day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wired Magnetic Assisted Capsule Endoscopy | MACE will be advised to keep their lips closed and wear a surgical mask during the examination. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased Oxygen Saturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | The participant experienced saliva aspiration coughing during esophagogastroduodenoscopy under anesthesia. |
The limitation of this study is that the sample size for each group is not large. This limitation is due to the rarity of biliary atresia, with an incidence of only 1.5 cases per 10,000 in Taiwan. Additionally, since the examination equipment differs between the two groups, a double-blind design could not be implemented.Because biliary atresia cases are prone to infection and bleeding, it is not ethically appropriate to have each patient undergo both groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jia-Feng Wu | National Taiwan University Hospital | +886 23123456 | 271718 | wjf@ntu.edu.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2024 | May 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| D001656 | Biliary Atresia |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| esophagogastroduodenoscopy |
| Device |
once |
|
We recorded the number of participants who had esophageal varices after completion of the examination.
| 1 day |
| Number of Participants With Gastric Varices | We recorded the number of participants who had gastric varices after completion of the examination. | 1 day |
| Questionnaire Assessments | 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. | 1 day |
| Examination Time | 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. | 1 day |
| Completion Rate | 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. | 1 day |
Participants in this group undergo esophagogastroduodenoscopy to assess esophageal varices, which is a traditional invasive method, with sedation based on the need. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body height | Median | Inter-Quartile Range | cm |
|
| Body weight | Median | Inter-Quartile Range | kg |
|
| Liver cirrhosis | Count of Participants | Participants |
|
| Ascites | Count of Participants | Participants |
|
| Splenomegaly | Count of Participants | Participants |
|
| Liver transplantation | Count of Participants | Participants |
|
| Conscious sedation | Count of Participants | Participants |
|
| < 19 years of age | Count of Participants | Participants |
|
| ALT | Median | Inter-Quartile Range | IU/mL |
|
| Platelet | Median | Inter-Quartile Range | K/uL |
|
| Hb | Median | Inter-Quartile Range | g/dL |
|
| WBC | Median | Inter-Quartile Range | K/uL |
|
| Total bilirubin | Median | Inter-Quartile Range | mg/dL |
|
| Direct bilirubin | Median | Inter-Quartile Range | mg/dL |
|
| OG001 | Wired Magnetic Assisted Capsule Endoscopy | In this study, 25 patients aged 6 years or older with biliary atresia undergoing Magnetic-Assisted Capsule Endoscopy (MACE) for esophageal varices survey will be enrolled as the "study group.Patients undergoing MACE will be advised to keep their lips closed and wear a surgical mask during the examination. |
|
|
| Secondary | Particles Generated Per Minute | The total number of particles of each size divided by examination time to calculate per-minute production; comparison between the two groups. | All 50 participants completed the trial. | Posted | Median | Inter-Quartile Range | Particles generated per minute | 1 day |
|
|
|
| Secondary | Number of Participants With Esophageal Varices | We recorded the number of participants who had esophageal varices after completion of the examination. | All 50 participants completed the trial. | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Number of Participants With Gastric Varices | We recorded the number of participants who had gastric varices after completion of the examination. | All 50 participants completed the trial. | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Questionnaire Assessments | 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. | All 50 participants completed the trial. | Posted | Median | Inter-Quartile Range | score on a scale | 1 day |
|
|
|
| Secondary | Examination Time | 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. | All 50 participants completed the trial. | Posted | Median | Inter-Quartile Range | min | 1 day |
|
|
|
| Secondary | Completion Rate | 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. | All 50 participants completed the trial. | Posted | Count of Participants | Participants | 1 day |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Esophagogastroduodenoscopy | Patients undergoing conventional EGD may choose to receive conscious sedation based on clinical needs. | 0 | 25 | 0 | 25 | 1 | 25 |
|
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| D008107 | Liver Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004065 | Digestive System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013514 | Surgical Procedures, Operative |
| D003938 | Diagnostic Techniques, Digestive System |
| D013505 | Digestive System Surgical Procedures |
| 1.0 μm per min |
|
| 2.5 μm per min |
|
| 4.0 μm per min |
|
| 5.0 μm per min |
|
| 7.0 μm per min |
|
| 10.0 μm per min |
|
| Duodenum |
|