Fernando Dip1,2, Emanuelle LoMenzo1, Luis Sarotto1, Edward Phillips3, Hernan Todeschini1, Mario Nahmod1, Lisandro Alle1, Sylke Schneider4, Ludwig Kaja4, Luigi Boni5, Pedro Ferraina1, Thomas Carus6, Norihiro Kokudo7, Takeaki Ishizawa7, Mathew Walsh8, Conrad Simpfendorfer2, Roy Mayank2, Kevin White9, Raul J Rosenthal2. 1. Department of Surgery, Hospital de Clínicas José de San Martín, University of Buenos Aires, Buenos Aires, Argentina. 2. Department of General Surgery, Cleveland Clinic Florida, Weston, FL. 3. Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA. 4. Department of Surgery, Klinikum Südstadt Südring 81, Rostock, Germany. 5. General and Emergency Surgery IRCCS-Ca' Granda-Policlinico Hospital, University of Milan|UNIMI, Milan, Italy. 6. Department of Surgery, Asklepios Westklinikum Suurheid 20, Hamburg, Germany. 7. Faculty of Medicine University Hospital, Artificial Organ and Transplantation Surgery, University of Tokyo, Tokyo, Japan. 8. Cleveland Clinic, Cleveland, OH. 9. ScienceRight Editing and Publishing, London, ON, Canada.
Abstract
BACKGROUND:Incisionless near-infrared fluorescent cholangiography (NIFC) is emerging as a promising tool to enhance the visualization of extrahepatic biliary structures during laparoscopic cholecystectomies. METHODS: We conducted a single-blind, randomized, 2-arm trial comparing the efficacy of NIFC (n = 321) versus white light (WL) alone (n = 318) during laparoscopic cholecystectomy. Using the KARL STORZ Image1 S imaging system with OPAL1 technology for NIR/ICG imaging, we evaluated the detection rate for 7 biliary structures-cystic duct (CD), right hepatic duct (RHD), common hepatic duct, common bile duct, cystic common bile duct junction, cystic gallbladder junction (CGJ), and accessory ducts -before and after surgical dissection. Secondary calculations included multivariable analysis for predictors of structure visualization and comparing intergroup biliary duct injury rates. RESULTS:Predissection detection rates were significantly superior in the NIFC group for all 7 biliary structures, ranging from 9.1% versus 2.9% to 66.6% versus 36.6% for the RHD and CD, respectively, with odds ratios ranging from 2.3 (95% CI 1.6-3.2) for the CGJ to 3.6 (1.6-9.3) for the RHD. After dissection, similar intergroup differences were observed for all structures except CD and CGJ, for which no differences were observed. Significant odds ratios ranged from 2.4 (1.7-3.5) for the common hepatic duct to 3.3 (1.3-10.4) for accessory ducts. Increased body mass index was associated with reduced detection of most structures in both groups, especially before dissection. Only 2 patients, both in the WL group, sustained a biliary duct injury. CONCLUSIONS: In a randomized controlled trial, NIFC was statistically superior to WL alone visualizing extrahepatic biliary structures during laparoscopic cholecystectomy. REGISTRATION NUMBER: NCT02702843.
RCT Entities:
BACKGROUND: Incisionless near-infrared fluorescent cholangiography (NIFC) is emerging as a promising tool to enhance the visualization of extrahepatic biliary structures during laparoscopic cholecystectomies. METHODS: We conducted a single-blind, randomized, 2-arm trial comparing the efficacy of NIFC (n = 321) versus white light (WL) alone (n = 318) during laparoscopic cholecystectomy. Using the KARL STORZ Image1 S imaging system with OPAL1 technology for NIR/ICG imaging, we evaluated the detection rate for 7 biliary structures-cystic duct (CD), right hepatic duct (RHD), common hepatic duct, common bile duct, cystic common bile duct junction, cystic gallbladder junction (CGJ), and accessory ducts -before and after surgical dissection. Secondary calculations included multivariable analysis for predictors of structure visualization and comparing intergroup biliary duct injury rates. RESULTS: Predissection detection rates were significantly superior in the NIFC group for all 7 biliary structures, ranging from 9.1% versus 2.9% to 66.6% versus 36.6% for the RHD and CD, respectively, with odds ratios ranging from 2.3 (95% CI 1.6-3.2) for the CGJ to 3.6 (1.6-9.3) for the RHD. After dissection, similar intergroup differences were observed for all structures except CD and CGJ, for which no differences were observed. Significant odds ratios ranged from 2.4 (1.7-3.5) for the common hepatic duct to 3.3 (1.3-10.4) for accessory ducts. Increased body mass index was associated with reduced detection of most structures in both groups, especially before dissection. Only 2 patients, both in the WL group, sustained a biliary duct injury. CONCLUSIONS: In a randomized controlled trial, NIFC was statistically superior to WL alone visualizing extrahepatic biliary structures during laparoscopic cholecystectomy. REGISTRATION NUMBER: NCT02702843.
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