A new method of near-infrared fluorescence image-guided hepatectomy for patients with hepatolithiasis: a randomized controlled trial

Background: Hepatectomy is a definitive treatment for hepatolithiasis because it simultaneously removes intrahepatic duct (IHD) stones and biliary tract strictures together with the involved liver region en bloc. Unlike cystic or solid liver tumors, hepatolithiasis is usually associated with alterations of anatomical structures and perihepatic adhesions because of chronic recurrent inflammation. This complicates identification of the target hepatic region and location of biliary strictures. Methods: To determine the efficacy of near-infrared fluorescence (NIRF) imaging using indocyanine green (ICG), we performed a comparative trial and developed a white-light and near-infrared dual-channel image-guided device (DPM-I) for both open and endoscopic surgery. Forty-four eligible patients were randomly assigned to Group A (NIRF imaging) or Group B (traditional hepatectomy). We injected ICG via peripheral veins for patients in Group A. Results: The NIRF imaging method was associated with less blood loss (OR 1.004, 95% CI 0.999–1.010; P = 0.016), briefer hospitalization (OR 1.336, 95% CI 1.016–1.756; P = 0.001), lower rates of margins with dilated bile ducts (OR 1.278, 95% CI 1.030–1.585; P = 0.023), lower postoperative white blood cell counts (OR 1.262, 95% CI 0.931–1.712; P = 0.038), lower procalcitonin levels (OR 1.316, 95% CI 1.020–1.513; P = 0.002), and lower alanine aminotransferase levels (OR 1.013, 95% CI 1.003–1.023; P = 0.002) compared with traditional hepatectomy. Conclusions: These data demonstrate the efficacy of NIRF imaging with ICG using DPM-I for treating hepatolithiasis.