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

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Abstract

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.

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Acknowledgements

This study was supported by the Ministry of Science and Technology of the People’s Republic of China (MOST) (2017YFA0205200, 2017YFA0700401, 2016YFA0100902, 2019YFC0120800), National Natural Science Foundation of China (NSFC) (81527805, 81971773), Key Research Projects in Frontier Science of Chinese Academy of Sciences (CAS) (QYZDJ-SSW-JSC005, KFJ-STS-ZDTP-059), Natural Science Foundation of Guangdong Province of China (2018A0303130292, 2019A1515011356), and Project of Administration of Traditional Chinese Medicine of Guangdong Province of China (20181062), China Postdoctoral Science Foundation (2019M660409). The Clinical Trails was registered with the name of Near-infrared Fluorescence Imaging Applied in Hepatolithiasis with Indocyanine Green, and No. ChiCTR1800020031. http://www.chictr.org.cn/showproj.aspx?proj=32467.

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Correspondence to Jian Li, Hong Shan or Jie Tian.

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Disclosures

Kunshan He, Xiaopeng Hong, Chongwei Chi, Chaonong Cai, Kun Wang, Peiping Li, Xialei Liu, Jian Li, Hong shan, and Jie Tian have no conflict of interest to declare.

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He, K., Hong, X., Chi, C. et al. A new method of near-infrared fluorescence image-guided hepatectomy for patients with hepatolithiasis: a randomized controlled trial. Surg Endosc 34, 4975–4982 (2020). https://doi.org/10.1007/s00464-019-07290-z

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