Department of Gastrointestinal and Pediatric Surgery, Tottori University Faculty of Medicine Graduate School of Medicine, Yonago, Tottori, Japan
Department of Gastrointestinal and Pediatric Surgery, Tottori University Faculty of Medicine Graduate School of Medicine, Yonago, Tottori, Japan.
BMJ Open. 2023 Mar 21;13(3):e068223. doi: 10.1136/bmjopen-2022-068223.
Bile leakage (BL) after hepatectomy cannot always be detected with conventional methods; moreover, BL cannot be completely prevented. Recently, navigation procedures with indocyanine green (ICG) have been reported. Furthermore, we previously reported the possibility of detecting BLs with high sensitivity during hepatectomy by administering ICG into the bloodstream, which is quickly excreted in the bile. This study aims to verify whether detecting and addressing ICG leakage from the hepatic dissection plane using an ICG camera can reduce the bilirubin concentration in the drainage fluid, and consequently, the incidence of BL.
This prospective single-centre non-randomised single-arm trial will be conducted with historical controls. Overall, 85 patients will be enrolled, including 40 and 45 in the ICG and historical control groups, respectively. In the ICG group, 10 mg/2 mL of ICG will be transvenously or transportally administered during liver surgery. After its uptake by liver cells and excretion into bile, it will be visualised using a camera following the completion of hepatectomy, and the site of ICG leakage will be sutured. Moreover, we will record the number of bile leak spots detected by the naked eye and ICG camera. The primary endpoint of the study will be the total bilirubin concentration in the drain fluid on postoperative day 3, and we will determine whether the concentration differs significantly between the ICG and historical control groups. The results of our study will be used to suggest whether intraoperative ICG administration and evaluation at the hepatic dissection plane can be widely used in liver surgery for more reliable detection of BL and consequent reduction of biliary fistula.
The protocol was approved by the Certified Review Board of Tottori University Hospital (approval number: 21C002). Findings from this trial will be published in peer-reviewed journals and presented at academic conferences.
jRCTs061210043.
肝切除术后的胆汁漏（BL）不能总是通过常规方法检测到；此外，BL 也不能完全预防。最近，已有使用吲哚菁绿（ICG）进行导航程序的报道。此外，我们之前报道过通过向血流中注入 ICG 来检测肝切除术中 BL 的高灵敏度的可能性，ICG 会迅速从胆汁中排出。本研究旨在验证使用 ICG 相机检测和处理肝解剖面的 ICG 泄漏是否可以降低引流液中的胆红素浓度，从而降低 BL 的发生率。
这是一项前瞻性单中心非随机单臂试验，将与历史对照进行比较。总共将纳入 85 例患者，其中 ICG 组和历史对照组分别为 40 例和 45 例。在 ICG 组中，肝手术期间将静脉或经肝管给予 10mg/2mL 的 ICG。ICG 被肝细胞摄取并排入胆汁后，在肝切除术后使用相机进行可视化，并缝合 ICG 泄漏部位。此外，我们将记录肉眼和 ICG 相机检测到的胆汁漏点的数量。该研究的主要终点是术后第 3 天引流液中的总胆红素浓度，我们将确定 ICG 组和历史对照组之间的浓度是否有显著差异。我们的研究结果将用于表明术中 ICG 给药和肝解剖面评估是否可以在肝外科中广泛应用，以更可靠地检测 BL 并减少胆瘘。
该方案已获得鸟取大学医院认证审查委员会的批准（批准号：21C002）。本试验的结果将发表在同行评议的期刊上，并在学术会议上展示。
jRCTs061210043。
