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Study on the Optimal Dosing Regimen of Indocyanine Green for Fluorescence Laparoscopy in Biliary Visualization

Study on the Optimal Dosing Regimen of Indocyanine Green for Fluorescence Laparoscopy in Biliary Visualization

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112865
Enrollment
Unknown
Registered
2025-11-20
Start date
2024-03-13
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Benign gallbladder disease

Interventions

A1:The intervention consisted of an intravenous injection of 0.25 mg ICG, administered within the window of 0 to 3 hours before the laparoscopic cholecystectomy.
A2:The intervention consisted of an intravenous injection of 0.50 mg ICG, administered within the window of 0 to 3 hours before the laparoscopic cholecystectomy.
A3:The intervention consisted of an intravenous injection of 1.00 mg ICG, administered within the window of 0 to 3 hours before the laparoscopic cholecystectomy.
A4:The intervention consisted of an intravenous injection of 2.50 mg ICG, administered within the window of 0 to 3 hours before the laparoscopic cholecystectomy.
A5:The intervention consisted of an intravenous injection of 0.25 mg ICG, administered within the window of 3 to 6 hours before the laparoscopic cholecystectomy.
A6:The intervention consisted of an intravenous injection of 0.50 mg ICG, administered within the window of 3 to 6 hours before the laparoscopic cholecystectomy.
A7:The intervention consisted of an intravenous injection of 1.00 mg ICG, administered within the window of 3 to 6 hours before the laparoscopic cholecystectomy.
A8:The intervention consisted of an intravenous injection of 2.50 mg ICG, administered within the window of 3 to 6 hours before the laparoscopic cholecystectomy.
A9:The intervention consisted of an intravenous injection of 0.25 mg ICG, administered within the window of 6 to 9 hours before the laparoscopic cholecystectomy.
A10:The intervention consisted of an intravenous injection of 0.50 mg ICG, administered within the window of 6 to 9 hours before the laparoscopic cholecystectomy.
A11:The intervention consisted of an intravenous injection of 1.00 mg ICG, administered within the window of 6 to 9 hours before the laparoscopic cholecystectomy.
A12:The interven

Sponsors

Shijiazhuang People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Participants must be adults aged between 18 and 85 years with complete clinical data; 2. Preoperative diagnosis of benign gallbladder disease must be established through detailed medical history, physical examination, and at least one auxiliary imaging modality (e.g., abdominal ultrasound, CT, or MRI); 3. Patients must meet the indications for laparoscopic cholecystectomy; 4. Child-Pugh classification must be Grade A; 5. Patients should not undergo any other abdominal surgery during the current hospitalization.

Exclusion criteria

Exclusion criteria: 1. History of allergy to iodine or indocyanine green; 2. Liver function classified as Child-Pugh B or C; 3. Patients with severe coagulopathy or poor cardiopulmonary function, unable to tolerate surgery or anesthesia; 4. Biliary obstruction or bile metabolism disorder; 5. Presence of malignant tumors in the gallbladder or liver.

Design outcomes

Primary

MeasureTime frame
The bile duct-to-liver fluorescence contrast ratio;Subjective success rate of visualization;

Secondary

MeasureTime frame
Operation time;Blood loss;

Countries

China

Contacts

Public ContactGu Jianbin

Shijiazhuang People’s Hospital

2908270202@qq.com+86 176 0311 3060

Outcome results

None listed

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