Extrahepatic Biliary Tree Injury
Conditions
Keywords
icg, fluorescent cholangiograph
Brief summary
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
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.
Interventions
DRUGIndocyanine green
Indocyanine Green 25mg kit for injection
Sponsors
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The patient has indications for cholecystectomy and requires laparoscopic treatment； 2. 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
1. Patients who require emergency surgical treatment； 2. Patients with malignant tumors of the biliary tract； 3. Patients with a history of abdominal surgery； 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Common bile duct-to-liver fluorescence intensity ratio | Intraoperative (The beginning of the surgery) | Common bile duct-to-liver fluorescence intensity ratio |
Countries
China
Outcome results
None listed