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

NCT05376540 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-03-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • Ostfold Hospital Trust

    lead OTHER

Principal Investigators

  • Tom Nordby, MD, PhD · Ostfold Hospital Trust, Norway

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05376540 on ClinicalTrials.gov