Fluorescence Cholangiography During Cholecystectomy - a RCT

Study Overview
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Brief Summary
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The primary objective is to compare the success rates of intraoperative fluorescent cholangiography using indocyanine green versus conventional X-ray cholangiography for the identification of bile duct anatomy during laparoscopic cholecystectomy for complicated gallstone disease in a randomized design with 120 patients.

Official Title
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Fluorescence Cholangiography Versus X-ray Cholangiography During Laparoscopic Cholecystectomy for Complicated Gallstone Disease

Conditions
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Gallstones, Cholecystitis

Intervention / Treatment
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* Drug: Indocyanine green
* Device: Near-infrared illumination
* Drug: Urografin
* Radiation: X-ray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for planned laparoscopic cholecystectomy by one surgeon Complicated gallstone disease Exclusion Criteria: Open cholecystectomy Allergy towards iodine, urografin or indocyanine green Liver or renal insufficiency Thyrotoxicosis Pregnancy or lactation Legally incompetent for any reason Withdrawal of inclusion consent at any time

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescence cholangiography<br>After induction of anaesthesia 2.5-7.5 mg of indocyanine green (0.05 mg/kg) is injected intravenously. The operation field is routinely inspected in the fluorescence imaging mode before dissection of Calot´s triangle. During dissection, the fluorescence imaging mode is used when needed, before division of any tubular structure and after division of the cystic duct and artery. | Drug: Indocyanine green<br> <br> Device: Near-infrared illumination<br>* To see the fluorescence from indocyanine green<br>|
| Active Comparator: X-ray cholangiography<br>The cholangiography is performed after dissection of the cystic duct by cannulation of the cystic duct with a catheter using either a Kumar- or Olsen grasper. A mobile X-ray C-arm system is used, and the monochrome X-ray image is shown on a separate screen. After satisfactory identification of the extra-hepatic biliary ducts, the intraoperative cholangiography is discontinued and the gallbladder is removed in a standardized manner. | Drug: Urografin<br> <br> Radiation: X-ray<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualization of the cystic duct - common hepatic duct - common bile duct junction |  | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography |  | Intraoperative | 
| Surgeon satisfaction score (Measured on a 5 point VAS scale) | Measured on a 5 point VAS scale | Intraoperative | 
| Per-/postoperative adverse events as a measure of safety and tolerability |  | Intraoperative | 
| Total cost of operation incl fluorescent/conventional X-ray cholangiography |  | Admission to discharge from hospital (0-30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorescence, Cholangiography, Indocyanine Green, Cholecystectomy, Laparoscopic