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This study was to test an appropriate dose of fluorescein sodium which can provide high image quality to ensure endoscopy examination and have no yellow dye in the skin by a randomized blinded controlled trial.
Fluorescein sodium is one of the commonly used staining agents in confocal laser endoscopy, a device for in vivo real-time histological observation of the gastrointestinal mucosa. The conventional intravenous dosage of fluorescein sodium is in the range of 5ml to 10ml of 10% fluorescein. Image quality can be guaranteed with this range of fluorescein sodium, but yellow discoloration of the skin seriously influences daily life. This study was to test whether a lower dose of fluorescein sodium, which has minimal discoloration of skin, can provide satisfied image quality by a randomized blinded controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | This group patients were given dosages of fluorescein sodium 0.01ml/kg intravenous administration. |
|
| group 2 | Experimental | This group patients were given dosages of fluorescein sodium 0.02ml/kg intravenous administration. |
|
| group 3 | Experimental | This group patients were given dosages of fluorescein sodium 0.05ml/kg intravenous administration. |
|
| group 4 | Active Comparator | This group patients were given dosages of fluorescein sodium 0.1ml/kg intravenous administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorescein sodium 0.01ml/kg | Drug | fluorescein Sodium Dose of 0.01ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Different ratios of high resolution CLE images among four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg) | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Different degrees of skin yellow dye of patients in four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg) | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanqing Li, PhD.MD | Contact | 18678827666 | 82169508 | qiluliyanqing@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanqing Li, PhD.MD | Department of Gastroenterology,Qilu Hospital,Shandong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Qilu Hospital, Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| fluorescein sodium 0.02ml/kg | Drug | fluorescein Sodium Dose of 0.02ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin |
|
| fluorescein sodium 0.05ml/kg | Drug | fluorescein Sodium Dose of 0.05ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin |
|
| fluorescein sodium 0.1ml/kg | Drug | fluorescein Sodium Dose of 0.1ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin |
|
| ID | Term |
|---|---|
| D019793 | Fluorescein |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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