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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05376540
Enrollment
100
Registered
2022-05-17
Start date
2023-03-03
Completion date
2024-12-31
Last updated
2023-03-29

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

Conditions

Cholecystitis, Gall Stone

Keywords

Cholecystectomy, Flourescent cholangiography

Brief 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.

Interventions

PROCEDUREDirect gallbladder injection of ICG intraoperatively

Patients randomized to this arm will have 2.5 mg ICG injected directly into the gallbladder intraoperatively.

PROCEDUREIntravenous injection 2.5 mg

Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prio to surgery

PROCEDUREIntravenous 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.

PROCEDUREIntravenous injection 5 mg

Patients randomized to this arm will have 5 mg ICG injected intravenously 0-8 hours prior to surgery

Sponsors

Oslo University Hospital
CollaboratorOTHER
Ostfold Hospital Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Indication for laparoscopic cholecystectomy * Signed informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
A questionnaire will be used to evaluate the surgeons experience.3-4 monthsThis study aims to compare the surgeons subjective experience of ICG utility for different dosages and route of administration of indocyanine green in patients operated with laparoscopic cholecystectomy. A questionnaire will be used to evaluate the surgeons experience.

Countries

Norway

Contacts

Primary ContactCarl-Philip Rancinger, MD
carl-philip.rancinger@so-hf.no+4769860000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026