吲哚菁绿荧光导航联合三维可视化技术在腹腔镜肝内胆管细胞癌解剖性肝切除及区域淋巴结清扫中的应用价值
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南阳医学高等专科学校第一附属医院 普通外科三病区,河南 南阳 473000

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贾亚鹏,南阳医学高等专科学校第一附属医院主治医师,主要从事胆囊、胆道、肝脏方面的研究。

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Application value of indocyanine green fluorescence navigation combined with three-dimensional visualization technology in laparoscopic anatomical hepatectomy and regional lymph node dissection for intrahepatic cholangiocarcinoma
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Ward 3, Department of General Surgery, the First Affiliated Hospital of Nanyang Medical College, Nanyang, Henan 473000, China

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    摘要:

    背景与目的 肝内胆管细胞癌(ICC)恶性程度高,根治性切除是目前获得长期生存的主要治疗手段。腹腔镜解剖性肝切除及区域淋巴结清扫对肝脏解剖结构识别和手术操作精度要求较高。三维可视化技术可辅助术前个体化手术规划,吲哚菁绿(ICG)荧光导航可提供术中实时成像,二者联合应用有望提高手术精准性。本研究探讨ICG荧光导航联合三维可视化技术在腹腔镜ICC解剖性肝切除及区域淋巴结清扫中的应用价值。方法 采用前瞻性、单中心、开放标签、随机对照研究设计,纳入2023年4月—2025年4月南阳医学高等专科学校第一附属医院接受腹腔镜ICC根治性切除的122例患者,采用随机数字表法按1∶1分为常规组和联合组,各61例。常规组行腹腔镜ICC根治性切除,联合组在常规手术基础上应用ICG荧光导航联合三维可视化技术。比较两组术中指标、术后近期恢复指标、术后并发症、肿瘤复发及生存情况。主要终点采用意向性分析(ITT)评价,并以符合方案集(PPS)分析进行支持性验证。结果 PPS分析显示,联合组肝门阻断时间、术中出血量及术中输血率均低于常规组(均P<0.05),解剖性肝切除符合率、淋巴结清扫达标率及R0切除率均高于常规组(均P<0.05);联合组淋巴结清扫总数及阳性淋巴结数均多于常规组(均P<0.05),且额外检出卫星灶8例,而常规组未检出。联合组引流管拔除时间及住院时间均短于常规组,术后3 d丙氨酸氨基转移酶、天冬氨酸氨基转移酶及总胆红素水平均低于常规组(均P<0.05)。联合组术后并发症总发生率低于常规组(5.36% vs. 19.64%,P=0.022)。1年区域淋巴结复发率低于常规组(3.57% vs. 14.29%,P=0.047),而1年肝内复发率及远处转移率组间差异无统计学意义(均P>0.05)。生存分析显示,联合组无进展生存时间长于常规组(中位时间:30个月 vs. 26个月,P=0.037),两组总生存时间差异无统计学意义(中位时间:32个月 vs. 27个月,P=0.215)。ITT分析结果与PPS分析总体一致。结论 ICG荧光导航联合三维可视化技术应用于腹腔镜ICC解剖性肝切除及区域淋巴结清扫,有助于提高手术解剖定位及淋巴结清扫的精准性,减少术中出血和肝门阻断时间,改善术后恢复,并可能降低区域淋巴结复发风险、延长无进展生存时间,但其对长期总生存的影响仍需更大样本、多中心研究进一步验证。

    Abstract:

    Background and Aims Intrahepatic cholangiocarcinoma (ICC) is a highly aggressive primary liver malignancy, and radical resection remains the main treatment option for achieving long-term survival. Laparoscopic anatomical hepatectomy and regional lymph node dissection require precise identification of hepatic anatomy and accurate surgical manipulation. Three-dimensional visualization technology facilitates individualized preoperative surgical planning, whereas indocyanine green (ICG) fluorescence navigation provides real-time intraoperative imaging. This study investigated the clinical value of combining ICG fluorescence navigation with three-dimensional visualization technology in laparoscopic anatomical hepatectomy and regional lymph node dissection for ICC.Methods This prospective, single-center, open-label, randomized controlled study included 122 patients who underwent laparoscopic radical resection for ICC between April 2023 and April 2025. Patients were randomly assigned at a 1∶1 ratio to a conventional group or a combined group, with 61 patients in each group. Patients in the conventional group underwent laparoscopic radical resection alone, whereas those in the combined group received ICG fluorescence navigation combined with three-dimensional visualization in addition to the conventional procedure. Intraoperative parameters, short-term postoperative recovery, postoperative complications, tumor recurrence, and survival outcomes were compared between the groups. The primary endpoints were evaluated according to the intention-to-treat (ITT) principle, with per-protocol set (PPS) analysis performed as a supportive analysis.Results In the PPS analysis, the combined group had shorter hepatic portal occlusion time, less intraoperative blood loss, and a lower intraoperative transfusion rate than the conventional group (all P<0.05). The rates of compliant anatomical hepatectomy, adequate lymph node dissection, and R0 resection were higher in the combined group (all P<0.05). The combined group also had a greater total number of dissected lymph nodes and positive lymph nodes (both P<0.05), and eight satellite lesions were additionally detected in the combined group compared with none in the conventional group. The drainage tube removal time and hospital stay were shorter, and postoperative day 3 levels of alanine aminotransferase, aspartate aminotransferase, and total bilirubin were lower in the combined group (all P<0.05). The overall incidence of postoperative complications was lower in the combined group than in the conventional group (5.36% vs. 19.64%, P=0.022). The 1-year regional lymph node recurrence rate was also lower in the combined group (3.57% vs. 14.29%, P=0.047), whereas no significant differences were observed in 1-year intrahepatic recurrence or distant metastasis rates (both P>0.05). Survival analysis showed that the combined group had longer progression-free survival than the conventional group (median, 30 months vs. 26 months; P=0.037), while overall survival did not differ significantly between the groups (median, 32 months vs. 27 months; P=0.215). The ITT analysis yielded results generally consistent with those of the PPS analysis.Conclusion The combination of ICG fluorescence navigation and three-dimensional visualization technology in laparoscopic anatomical hepatectomy and regional lymph node dissection for ICC may improve the precision of anatomical localization and lymph node dissection, reduce intraoperative blood loss and hepatic portal occlusion time, and facilitate postoperative recovery. It may also reduce regional lymph node recurrence and prolong progression-free survival; however, its effect on long-term overall survival requires confirmation in larger multicenter studies.

    图1 两组患者的生存曲线 A:PFS;B:OSFig.1 Survival curves A: PFS; B: OS
    表 4 两组术后并发症比较[n(%)]Table 4 Comparison of postoperative complications between the two groups [n (%)]
    表 5 两组术后1年肿瘤复发及远处转移情况比较[n(%)]Table 5 Comparison of 1-year tumor recurrence and distant metastasis between the two groups [n (%)]
    表 6 ITT集两组术后1年肿瘤复发及远处转移情况比较[n(%)]Table 6 Comparison of 1-year tumor recurrence and distant metastasis between the two groups in the ITT set [n (%)]
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贾亚鹏,王虞,李永坤.吲哚菁绿荧光导航联合三维可视化技术在腹腔镜肝内胆管细胞癌解剖性肝切除及区域淋巴结清扫中的应用价值[J].中国普通外科杂志,2026,35(8):1553-1562.
DOI:10.7659/j. issn.1005-6947.260399

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  • 收稿日期:2026-07-03
  • 最后修改日期:2026-08-23
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