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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescence cholangiography | Experimental | 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. |
|
| X-ray cholangiography | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green | Drug |
| ||
| Near-infrared illumination |
| Measure | Description | Time Frame |
|---|---|---|
| Visualization of the cystic duct - common hepatic duct - common bile duct junction | Intraoperative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars ML Lehrskov-Schmidt, MD | Hvidovre University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32057103 | Result | Lehrskov LL, Westen M, Larsen SS, Jensen AB, Kristensen BB, Bisgaard T. Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial. Br J Surg. 2020 May;107(6):655-661. doi: 10.1002/bjs.11510. Epub 2020 Feb 14. | |
| 27477798 | Derived | Lehrskov LL, Larsen SS, Kristensen BB, Bisgaard T. Fluorescence versus X-ray cholangiography during laparoscopic cholecystectomy: protocol for a randomised trial. Dan Med J. 2016 Aug;63(8):A5261. |
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| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002769 | Cholelithiasis |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| D003974 | Diatrizoate Meglumine |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Device |
To see the fluorescence from indocyanine green |
|
| Urografin | Drug |
|
| X-ray | Radiation |
|
| 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) |
| D041761 |
| Cholecystolithiasis |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008536 | Meglumine |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D003973 | Diatrizoate |
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |