High Quality Fluorescent Cholangiography

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of the Fluorescent Visualization of the Extrahepatic Biliary Tract Between Two Injection Protocols

Conditions
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Extrahepatic Biliary Tree Injury

Intervention / Treatment
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* Drug: Indocyanine green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has indications for cholecystectomy and requires laparoscopic treatment； No biliary obstruction or cholestasis was found during preoperative examination；3.Volunteer to participate in this clinical trial and sign written informed consent. Exclusion Criteria: Patients who require emergency surgical treatment； Patients with malignant tumors of the biliary tract； Patients with a history of abdominal surgery； Patients who are allergic to indocyanine green or iodine contrast agents；5.Patients participating in one or more other clinical trials simultaneously； 6.Patients who have received medication that affects bile excretion within 2 weeks before surgery； 7.Other situations that have been judged unsuitable for inclusion by researchers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 day before surgery<br>0.25mg/kg Indocyanine Green will be administered 1 day before surgery | Drug: Indocyanine green<br>* Indocyanine Green 25mg kit for injection<br>|
| Experimental: 45 min before surgery<br>0.05mg Indocyanine Green will be administered 45minutes before surgery | Drug: Indocyanine green<br>* Indocyanine Green 25mg kit for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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icg, fluorescent cholangiograph