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The goal of this randomized controlled trial is to compare the quality of extrahepatic biliary fluorescent visualization under two injection protocols to optimize extrahepatic biliary cholangiography.
Biliary fluorescence imaging is widely used to identify the extrahepatic biliary tract during laparoscopic cholecystectomy. However, fluorescent developer Indocyanine Green(ICG) still lacks standardization, and not every visualization of the extrahepatic biliary tract is satisfactory. Some research groups have shown that injection of ICG 1 day before surgery can achieve the best fluorescence imaging of the biliary tract, but some research groups have suggested that injection of a very low dose of ICG 45 minutes before surgery can improve the satisfaction of fluorescence imaging. However, no study compares the quality of biliary fluorescence imaging between the two injection protocols. This study will compare the fluorescence imaging effects of the two schemes to obtain the best injection scheme at present and standardize the use of icg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 day before surgery | Active Comparator | 0.25mg/kg Indocyanine Green will be administered 1 day before surgery |
|
| 45 min before surgery | Experimental | 0.05mg Indocyanine Green will be administered 45minutes before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green | Drug | Indocyanine Green 25mg kit for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Common bile duct-to-liver fluorescence intensity ratio | Common bile duct-to-liver fluorescence intensity ratio | Intraoperative (The beginning of the surgery) |
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Inclusion Criteria:
Exclusion Criteria:
6.Patients who have received medication that affects bile excretion within 2 weeks before surgeryï¼› 7.Other situations that have been judged unsuitable for inclusion by researchers.
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| Name | Affiliation | Role |
|---|---|---|
| Jian Yang, MD | Zhujiang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Medical University | Guangzhou | Guangdong | 510000 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 28, 2024 | |
| Reset | Jul 12, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 28, 2024 | Jul 12, 2024 |
| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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