Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy
NCT ID: NCT05376540
Last Updated: 2023-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2023-03-03
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Direct gallbladder injection
2.5 mg of ICG will be injected directly into gallbladder intraoperatively.
Direct gallbladder injection of ICG intraoperatively
Patients randomized to this arm will have 2.5 mg ICG injected directly into the gallbladder intraoperatively.
2.5 mg intravenously
2.5 mg will ICG will be injected intravenously 1 hour prior to surgery.
Intravenous injection 2.5 mg
Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prio to surgery
2.5 mg intravenously + direct gallbladder injection
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.
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.
5 mg intravenously
5 mg ICG will be injected intravenously 0-8 hours prior to surgery.
Intravenous injection 5 mg
Patients randomized to this arm will have 5 mg ICG injected intravenously 0-8 hours prior to surgery
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
* Pregnancy or breast feeding
18 Years
99 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Ostfold Hospital Trust
OTHER
Responsible Party
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Principal Investigators
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Tom Nordby, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ostfold Hospital Trust, Norway
Locations
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Østfold Hospital trust
Moss, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REK280193
Identifier Type: -
Identifier Source: org_study_id
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