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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gall Stone, Cholecystitis

Intervention / Treatment
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* Procedure: Direct gallbladder injection of ICG intraoperatively
* Procedure: Intravenous injection 2.5 mg
* Procedure: Intravenous injection and direct gallbladder injection
* Procedure: Intravenous injection 5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for laparoscopic cholecystectomy Signed informed consent Exclusion Criteria: Allergy to indocyanine green or iodine Pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Direct gallbladder injection<br>2.5 mg of ICG will be injected directly into gallbladder intraoperatively. | Procedure: Direct gallbladder injection of ICG intraoperatively<br>* Patients randomized to this arm will have 2.5 mg ICG injected directly into the gallbladder intraoperatively.<br>|
| Other: 2.5 mg intravenously<br>2.5 mg will ICG will be injected intravenously 1 hour prior to surgery. | Procedure: Intravenous injection 2.5 mg<br>* Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prio to surgery<br>|
| Other: 2.5 mg intravenously + direct gallbladder injection<br>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. | Procedure: Intravenous injection and direct gallbladder injection<br>* 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.<br>|
| Other: 5 mg intravenously<br>5 mg ICG will be injected intravenously 0-8 hours prior to surgery. | Procedure: Intravenous injection 5 mg<br>* Patients randomized to this arm will have 5 mg ICG injected intravenously 0-8 hours prior to surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholecystectomy, Flourescent cholangiography