High Quality Fluorescent Cholangiography

Zhujiang Hospital168 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

168

Conditions

Extrahepatic Biliary Tree Injury

Interventions

Indocyanine greenDRUG

Indocyanine Green 25mg kit for injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Southern Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Common bile duct-to-liver fluorescence intensity ratio

Time frame: Intraoperative (The beginning of the surgery)

Data from ClinicalTrials.gov

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