High Quality Fluorescent Cholangiography (HQFC)

Zhujiang Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Extrahepatic Biliary Tree Injury

Treatments: Drug: Indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT05926856

20230420

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

168 participants in 2 patient groups

1 day before surgery

Active Comparator group

Description:

0.25mg/kg Indocyanine Green will be administered 1 day before surgery

Treatment:

Drug: Indocyanine green

45 min before surgery

Experimental group

Description:

0.05mg Indocyanine Green will be administered 45minutes before surgery

Treatment:

Drug: Indocyanine green