An interventional study of Indocyanine green and Near-infrared illumination in Cholecystitis and Gallstones, sponsored by Hvidovre University Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Prevention
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.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 120 is above the median of 86 across 167 interventional studies indexed under Cholecystitis.
Browse Cholecystitis studies →Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.
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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 · Device: Near-infrared illumination
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 · Radiation: X-ray
To see the fluorescence from indocyanine green
Visualization of the cystic duct - common hepatic duct - common bile duct junction
Time frame: Intraoperative
Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography
Time frame: Intraoperative
Surgeon satisfaction score (Measured on a 5 point VAS scale)
Measured on a 5 point VAS scale
Time frame: Intraoperative
Per-/postoperative adverse events as a measure of safety and tolerability
Time frame: Intraoperative
Total cost of operation incl fluorescent/conventional X-ray cholangiography
Time frame: Admission to discharge from hospital (0-30 days)
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Hvidovre University Hospital