NCT05376540

Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ostfold Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare different dosages and ways of administration of indocyanine green during fluorescent cholangiography in laparoscopic cholecystectomy. The study is randomized.

Conditions

• Gall Stone
• Cholecystitis

Interventions

Type	Name	Description
PROCEDURE	Direct gallbladder injection of ICG intraoperatively	Patients randomized to this arm will have 2.5 mg ICG injected directly into the gallbladder intraoperatively.
PROCEDURE	Intravenous injection 2.5 mg	Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prio to surgery
PROCEDURE	Intravenous injection and direct gallbladder injection	Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prior to surgery and another 2.5 mg ICG injected directly into the gallbladder, intraoperatively.
PROCEDURE	Intravenous injection 5 mg	Patients randomized to this arm will have 5 mg ICG injected intravenously 0-8 hours prior to surgery

Timeline

• Start date: 2023-03-03
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-05-17
• Last updated: 2023-03-29

Locations

1 site across 1 country: Norway