Dataset Information

Real-time navigation during hepatectomy using fusion indocyanine green-fluorescence imaging: protocol for a prospective cohort study.

ABSTRACT:

Introduction

In-vivo fluorescence imaging techniques using indocyanine green (ICG) to identify liver tumours and hepatic segment boundaries have been recently developed. The purpose of this study is to evaluate the efficacy of fusion ICG-fluorescence imaging for navigation during hepatectomy.

Methods and analysis

This will be an exploratory single-arm clinical trial; patients with liver tumours will undergo hepatectomy using the ICG-fluorescence imaging system. In total, 110 patients with liver tumours scheduled for elective hepatectomy will be included in this study. Preoperatively, ICG will be intravenously injected at a dose of 0.5?mg/kg body weight within 2 days. To detect liver tumours intraoperatively, the hepatic surface will be initially observed using the ICG-fluorescence imaging system. After identifying and clamping the portal pedicle corresponding to the hepatic segments, including the liver tumours to be resected, additional ICG will be injected intravenously at a dose of 0.5?mg/kg body weight to identify the boundaries of the hepatic segments. The primary outcome measure will be the success or failure of the ICG-fluorescence imaging system in identifying hepatic segments. The secondary outcomes will be the success or failure in identifying liver tumours, liver function indicators, operative time, blood loss, rate of postoperative complications and recurrence-free survival. The findings obtained through this study are expected to help to establish the utility of ICG-fluorescence imaging systems, and therefore contribute to prognostic outcome improvements in patients undergoing hepatectomy for various causes.

Ethics and dissemination

The protocol has been approved by the Kobe University Clinical Research Ethical Committee. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations.

Trial registration number

UMIN000031054 and jRCT1051180070.

SUBMITTER: Gon H

PROVIDER: S-EPMC6701684 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

Real-time navigation during hepatectomy using fusion indocyanine green-fluorescence imaging: protocol for a prospective cohort study.

Gon Hidetoshi H Komatsu Shohei S Murakami Sae S Kido Masahiro M Tanaka Motofumi M Kuramitsu Kaori K Tsugawa Daisuke D Awazu Masahide M Toyama Hirochika H Fukumoto Takumi T

BMJ open 20190818 8

<h4>Introduction</h4>In-vivo fluorescence imaging techniques using indocyanine green (ICG) to identify liver tumours and hepatic segment boundaries have been recently developed. The purpose of this study is to evaluate the efficacy of fusion ICG-fluorescence imaging for navigation during hepatectomy.<h4>Methods and analysis</h4>This will be an exploratory single-arm clinical trial; patients with liver tumours will undergo hepatectomy using the ICG-fluorescence imaging system. In total, 110 patie ...[more]

PMID: 31427337

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Project description:BackgroundThe naked-eye invisibility of indocyanine green fluorescence limits the application of near-infrared fluorescence imaging (NIR) systems for real-time navigation during sentinel lymph node biopsy (SLNB) in patients with breast cancer undergoing surgery. This study aims to evaluate the effectiveness and safety of a novel NIR system in visualizing indocyanine green fluorescence images in the surgical field and the application value of combined methylene blue (MB) and the novel NIR system in SLNB.MethodsSixty patients with clinical node-negative breast cancer received indocyanine green (ICG) and MB as tracers. Two NIR system instruments, namely, lymphatic fluorescence imaging system (LFIS) designed by the University of Science and Technology of China and vascular imager by Langfang Mingde Medical Biotechnology Co., Ltd. (Langfang vascular imager), were used as navigation assistance to locate sentinel lymph nodes (SLNs). Excising the lymph nodes developed by both MB and ICG by two NIR systems or palpably suspicious as SLNs and undergoing rapid pathological examination.ResultsBoth instruments exhibited 95% (57/60) success for real-time lymphatic fluorescent images. A total of 186 SLNs were identified, of which two were pathologically confirmed as lacking any lymph node tissue. SLN identification rate was 100% (184/184) for MB plus LFIS and 86.96% (160/184) for MB alone. The median number of SLNs identified by LFIS combined with MB was 3 (range of 1-8), which was significantly higher than that by MB alone at 2 (range 1-7) (P<0.05).ConclusionLFIS effectively detects SLNs in breast cancer, projects the fluorescence signals during surgery, and provides a continuous surgical navigation system without the need for a remote monitor. The ICG method navigated by combined LFIS and MB may be a promising alternative tracer for radioisotope in SLN mapping.Clinical trial registrationThis clinical trial was registered with the China Clinical Trial Center, registration number ChiCTR2000039542.

Project description:BackgroundLaparoscopic hepatectomy (LH) has achieved rapid progress over the last decade. However, it is still challenging to apply laparoscopy to lesions located in segments I, VII, VIII, and IVa and the hepatic hilar region due to difficulty operating around complex anatomical structures. In this study, we applied three-dimensional printing (3DP) and indocyanine green (ICG) fluorescence imaging technology to complex laparoscopic hepatectomy (CLH) to explore the effects and value of the modified procedure.Materials and methodsFrom January 2019 to January 2021, 54 patients with complex hepatobiliary diseases underwent LH at our center. Clinical data were collected from these patients and retrospectively analyzed.ResultsA total of 30 patients underwent CLH using the conventional approach, whereas 24 cases received CLH with 3DP technology and ICG fluorescent navigation. Preoperative data were compared between the two groups. In the 3DP group, we modified the surgical strategy of four patients (4/24, 16.7%) due to real-time intraoperative navigation with 3DP and ICG fluorescent imaging technology. We did not modify the surgical strategy for any patient in the non-3DP group (P = 0.02). There were no significant differences between the non-3DP and 3DP groups regarding operating time (297.7±104.1 min vs. 328.8±110.9 min, P = 0.15), estimated blood loss (400±263.8 ml vs. 345.8±356.1 ml, P = 0.52), rate of conversion to laparotomy (3/30 vs. 2/24, P = 0.79), or pathological outcomes including the incidence of microscopical R0 margins (28/30 vs. 24/24, P = 0.57). Additionally, there were no significant differences in postoperative complications or recovery conditions between the two groups. No instances of 30- or 90-day mortality were observed.ConclusionThe optimal surgical strategy for CLH can be chosen with the help of 3DP technology and ICG fluorescent navigation. This modified procedure is both safe and effective, but without improvement of intraoperative and short-term outcomes.

Dataset Information

Real-time navigation during hepatectomy using fusion indocyanine green-fluorescence imaging: protocol for a prospective cohort study.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Real-time navigation during hepatectomy using fusion indocyanine green-fluorescence imaging: protocol for a prospective cohort study.

Similar Datasets

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