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Investigation of optimal indocyanine green dose in real-time fluorescent cholangiography in laparoscopic cholecystectomy with an ultra-high definition 4K fluorescent system: a randomized controlled trial

Real-time fluorescent cholangiography with Indocyanine green in laparoscopic hepatobiliary surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064726
Enrollment
Unknown
Registered
2022-10-15
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extrahepatic biliary cholelithiasis

Interventions

Group A:The preoperative ICG injection volume is 1 µ g
Group B:The preoperative ICG injection volume is 10 µ g
Group C:The preoperative ICG injection volume is 25 µ g
Group D:The preoperative ICG injection volume is 100 µ g

Sponsors

Guangzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. Patients had indications for extrahepatic biliary tract surgery and could be operated on using laparoscopy; 2. Serum bilirubin was less than 30 µmol/L; 3. Imaging examinations, such as CT or ultrasound, did not detect cirrhosis; 4. Age >=18 years; 5. Patients who can listen, speak, read and understand the Chinese, can understand the requirements of the test and is willing to cooperate with the researcher to conduct the test, and voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of iodine allergy; 2. Patients with allergies to ICG or a history of allergies.

Design outcomes

Primary

MeasureTime frame
FI in bile duct;Fi in liver background;BLR;

Countries

China

Contacts

Public ContactWeili Gu

Guangzhou First People's Hospital

lili-6423@163.com+86 13922108036

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026