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NCT05376540 Clinical Trial

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

Cholecystitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05376540
Other study ID # REK280193
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 3, 2023
Est. completion date December 2024

Study information
Verified date March 2023
Source Ostfold Hospital Trust
Contact Carl-Philip Rancinger, MD
Phone +4769860000
Email carl-philip.rancinger@so-hf.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Indication for laparoscopic cholecystectomy - Signed informed consent Exclusion Criteria: - Allergy to indocyanine green or iodine - Pregnancy or breast feeding

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Direct gallbladder injection of ICG intraoperatively
Patients randomized to this arm will have 2.5 mg ICG injected directly into the gallbladder intraoperatively.
• Intravenous injection 2.5 mg
Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prio to surgery
• 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.
• Intravenous injection 5 mg
Patients randomized to this arm will have 5 mg ICG injected intravenously 0-8 hours prior to surgery

Locations
Country Name City State
Norway Østfold Hospital trust Moss

Sponsors (2)
Lead Sponsor Collaborator
Ostfold Hospital Trust Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary A questionnaire will be used to evaluate the surgeons experience. This 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. 3-4 months
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