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

Ostfold Hospital Trust

Status: Enrolling

Conditions: Cholecystitis; Gall Stone

Treatments: Procedure: Intravenous injection 5 mg; Procedure: Intravenous injection and direct gallbladder injection; Procedure: Intravenous injection 2.5 mg; Procedure: Direct gallbladder injection of ICG intraoperatively

Study type: Interventional

Funder types: Other

Identifiers

NCT05376540

REK280193

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for laparoscopic cholecystectomy
• Signed informed consent

Exclusion criteria

• Allergy to indocyanine green or iodine
• Pregnancy or breast feeding

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Direct gallbladder injection

Other group

Description:

2.5 mg of ICG will be injected directly into gallbladder intraoperatively.

Treatment:

Procedure: Direct gallbladder injection of ICG intraoperatively

2.5 mg intravenously

Other group

Description:

2.5 mg will ICG will be injected intravenously 1 hour prior to surgery.

Treatment:

Procedure: Intravenous injection 2.5 mg

2.5 mg intravenously + direct gallbladder injection

Other group

Description:

2.5 mg ICG will be injected intravenously 1 hour prior to surgery and another 2.5 mg ICG will be injected directly into the gallbladder intraoperatively.

Treatment:

Procedure: Intravenous injection and direct gallbladder injection

5 mg intravenously

Other group

Description:

5 mg ICG will be injected intravenously 0-8 hours prior to surgery.

Treatment:

Procedure: Intravenous injection 5 mg