Randomized Trial of Near-infrared Incisionless Fluorescent Cholangiography

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

Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial

“…The majority of previous investigations were small, prospective non‐controlled and controlled studies, and these indicated that the ability of fluorescence cholangiography to visualize the critical junction was equal to that of X‐ray cholangiography. A recent RCT including 639 patients compared fluorescence cholangiography with white light (normal vision) and not with X‐ray cholangiography as the standard. Improved visualization of the bile ducts by fluorescence cholangiography was reported (critical junction: 69 versus 45 per cent; P < 0·001).…”

“…A recent RCT including 639 patients compared fluorescence cholangiography with white light (normal vision) and not with X‐ray cholangiography as the standard. Improved visualization of the bile ducts by fluorescence cholangiography was reported (critical junction: 69 versus 45 per cent; P < 0·001). Although the success rate for visualization of the critical junction was lower than that in the present study, the success rate for visualizing the right hepatic duct was similar to the present findings (22 and 27 per cent respectively).…”

“…X‐ray cholangiography does not allow easy switching between X‐ray and white light (normal vision). The only RCT so far investigated the efficacy of fluorescence cholangiography compared with white light (normal vision). A drawback of X‐ray cholangiography is its time‐consuming nature.…”

Application of near-infrared fluorescent cholangiography using indocyanine green in laparoscopic cholecystectomy

“…NIRF-C provides the surgeon with a road map of the biliary tree in real time and at any time during dissection of Calot's triangle, 19 making it possible to perform rapid dissection of Calot's triangle without causing BDI. Dip et al 20 recently conducted a single-blind, randomized, two-arm trial comparing the efficacy of NIRF-C (n ¼ 321) versus white light alone (n ¼ 318) during LC. The authors concluded that NIRF-C was statistically superior to white light alone in visualizing extrahepatic biliary structures during LC.…”

Safe Cholecystectomy Multi-society Practice Guideline and State of the Art Consensus Conference on Prevention of Bile Duct Injury During Cholecystectomy

“…Narrative synthesis: The results of a single-blind multicenter, randomized controlled trial of NIR and white light (N = 321) to white light alone (N = 318) were not available prior to the consensus conference but has recently been published [122]. The trial compared detection rates of seven biliary structures: cystic duct (CD), right hepatic duct (RHD), common hepatic duct (CHD), and common bile duct (CBD), cystic-common bile duct junction (CCBDJ), cysticgallbladder junction (CGJ), and accessory ducts (AD).…”