Fluorescence Cholangiography During Cholecystectomy - a RCT
Not Applicable
Completed
- Conditions
- GallstonesCholecystitis
- Interventions
- Registration Number
- NCT02344654
- Lead Sponsor
- Hvidovre University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluorescence cholangiography Indocyanine green 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. Fluorescence cholangiography Near-infrared illumination 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 Urografin 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. X-ray cholangiography X-ray 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.
- Primary Outcome Measures
Name Time Method Visualization of the cystic duct - common hepatic duct - common bile duct junction Intraoperative
- Secondary Outcome Measures
Name Time Method Surgeon satisfaction score (Measured on a 5 point VAS scale) Intraoperative Measured on a 5 point VAS scale
Per-/postoperative adverse events as a measure of safety and tolerability Intraoperative Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography Intraoperative Total cost of operation incl fluorescent/conventional X-ray cholangiography Admission to discharge from hospital (0-30 days)