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High quality fluorescent visualization of extrahepatic biliary tract

High quality fluorescent visualization of extrahepatic biliary tract:A single center,open-label, randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083079
Enrollment
Unknown
Registered
2024-04-15
Start date
2023-09-07
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

benign gallbladder disease

Interventions

experimental group:Intravenous injection of indocyanine green at a dose of 0.05 mg 45 minutes before surgery
control group:Intravenous injection of indocyanine green at a dose of 0.25 milligrams per kilogram of body weight 16 hours before surgery

Sponsors

Zhujiang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) patients older than 18 and = 75 years old; (2) The patient had the indication of cholecystectomy and required fluorescence guided laparoscopic treatment; (3) Preoperative examination revealed no biliary obstruction or cholestasis; (4) Voluntarily participate in this clinical trial and sign a written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) patients requiring emergency surgery ; (2) patients with biliary malignancies; (3) Patients with a history of abdominal surgery; (4) Patients allergic to indocyanine green or iodine contrast media; (5) Patients who participate in one or more other clinical trials at the same time; (6) Patients who received drugs affecting bile excretion within 2 weeks before surgery; (7) Other circumstances that the investigator judged not suitable for enrollment.

Design outcomes

Secondary

MeasureTime frame
fluorescent intensity;visualization score of extrahepatic bile duct;

Primary

MeasureTime frame
fluorescent intensity ratio;Postoperative biliary leakage rate;

Countries

China

Contacts

Public ContactJian Yang

Zhujiang Hospital, Southern Medical University

yangjian486@126.com+86 137 6069 4012

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026