Randomized Trial of Near-infrared Incisionless Fluorescent Cholangiography.

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.

Novel technique for identification of ureters using sodium fluorescein.

BACKGROUND: The unique property of sodium fluorescein has made it ideal for use in medical applications such as diagnostic ophthalmology and intravenous angiography. It is mainly excreted via the renal system and although extensively used in these diagnostic applications, it has not been widely used to aid in the visualization of the ureters. It is possible to visualize the urinary tract by shining a source of light and studying the fluorescence using a special filter. The goal of our study was to assess the real-time visualization of ureters using intravenous sodium fluorescein under the stimulus of a 530 nm wavelength light. MATERIALS AND METHODS: Nine 250 gm Wister rats were given an intravenous dose of 0.01 ml of sodium fluorescein. A laparotomy was immediately performed following the administration of dye. Anesthesia was performed with an intraperitoneal dose of ketamine-xylazine. The retroperitoneum was exposed and observed under an alternating white xenon and a 530 nm excitation light with an objective to visualize the organs captured within the fluorescence of the compound (sodium fluorescein). RESULTS: Under xenon light, the location of the kidneys and urinary bladder were visualized, but not the ureters. The light was then changed to a 530 nm wavelength mode when the location and orientation of the ureters was visualized along with the peristaltic movements. Fluorescence visualization of the ureters was noted 5-10 min following kidney visualization. In addition, the vascular structures in close proximity to the ureters were also visualized. None of the rats underwent any retroperitoneal dissection, and in one case, partial mobilization of a kidney was undertaken. All rats were euthanized at the completion of the procedure. CONCLUSION: Intravenous administration of sodium fluorescein enables fluorescence visualization of the ureters in a rat model, after activation with a 530 nm light transmitter.