新型微波消融系统治疗血管旁与非血管旁肝癌的安全性及疗效

doi:10.3877/cma.j.issn.2095-3232.2025.06.012

目的

探讨具有臻圆^TM技术的Emprint^TM新型微波消融系统治疗血管旁与非血管旁肝癌的安全性及疗效。

方法

回顾性分析2019年1月至2022年9月在中山大学附属第三医院超声科行微波消融系统治疗的135例肝癌患者临床资料。研究符合医学伦理学规定。其中男120例，女15例；年龄27~83岁，中位年龄55岁。患者均使用Emprint^TM新型微波消融系统行超声引导下肝癌消融术。将纳入的患者根据肿瘤与肝内血管的邻近关系分为血管旁组（26例）和非血管旁组（109例）。使用倾向性评分匹配（PSM）的方法平衡组间的混杂因素。评价指标包括技术有效率、局部肿瘤进展（LTP）、肝内远处转移（IDM）、肝外转移（EM）、主要并发症等。率的比较采用χ²检验或Fisher确切概率法。

结果

消融术后1个月影像学检查显示，所有患者均未出现病灶残留或复发，消融技术有效率为100%。术后1年内，血管旁组和非血管旁组消融后均未出现LTP或EM；两组均出现了IDM，血管旁组消融术后1年的IDM率PSM前后分别为7.7%（2/26）、8.7%（2/23），非血管旁组相应为15.6%（17/109）、14.8%（8/54），但PSM前后两组差异均无统计学意义（χ²=1.084，0.534；P>0.05）。患者主要并发症发生率为3.0%（4/135），均发生在非血管旁组，包括胆汁湖形成2例、术后消化道出血1例、肠瘘1例，两组差异无统计学意义（P=1.00）。PSM后非血管旁组主要并发症发生率为5.6%（3/54），两组差异无统计学意义（P=0.55）。

结论

具备臻圆^TM技术的新型微波消融系统治疗血管旁的肝癌安全、有效，为此类困难病例提供了一种新的治疗方法。

关键词: 癌，肝细胞, 微波消融, 血管旁

Objective

To evaluate the safety and efficacy of Emprint^TM microwave ablation system with Thermosphere^TM technology in the treatment of perivascular and non-perivascular liver cancer.

Methods

Clinical data of 135 liver cancer patients treated with microwave ablation system in Department of Ultrasound of the Third Affiliated Hospital of Sun Yat-sen University were retrospectively analyzed. The local ethical committee approval was received. Among them, 120 patients were male and 15 females, aged from 27 to 83 years, with a median age of 55 years. All patients underwent ultrasound-guided ablation of liver cancer using Emprint^TM microwave ablation system. All patients were divided into the perivascular (n=26) and non-perivascular groups (n=109) according to adjacent relationship between tumors and intrahepatic vessels. Propensity score matching (PSM) was used to balance the confounding factors between two groups. The evaluation indexes included technical effective rate, local tumor progression (LTP), intrahepatic distant metastasis (IDM), extrahepatic metastasis (EM) and major complications. The rates were compared by Chi-square test or Fisher's exact test.

Results

At 1 month after ablation, imaging examination showed that all patients did not have residual lesions or recurrence, and the effective rate of ablation was 100%. Within 1 year after ablation, no LTP or EM was observed in two groups. IDM occurred in both two groups. In the perivascular group, the 1-year incidence rates of IDM before and after PSM were 7.7%(2/26) and 8.7%(2/23), and 15.6% (17/109) and 14.8%(8/54) in the non-perivascular group. No statistical significance was noted between 2 groups before and after PSM (χ²=1.084, 0.534; both P>0.05). The incidence of major complications was 3.0%(4/135), all of which occurred in the non-perivascular group, including 2 cases of bile lake formation, 1 case of postoperative gastrointestinal bleeding and 1 case of intestinal fistula. No statistical significance was observed between two groups (P=1.00). After PSM, the incidence of major complications in the non-perivascular group was 5.6%(3/54), and no statistical significance was found between two groups (P=0.55).

Conclusions

The novel microwave ablation system with Thermosphere^TM technology is a safe and efficacious treatment for perivascular liver cancer, which provides a new treatment option for such complicated cases.

Key words: Carcinoma, hepatocellular, Microwave ablation, Perivascular

表1 PSM前后两组肝癌患者消融术前基线资料比较

指标	匹配前				匹配后
指标	非血管旁组	血管旁组	SMD值	P值	非血管旁组	血管旁组	SMD值	P值
男性(例)	95	25	0.459	0.335	50	22	0.111	1.000
年龄 (岁, $x ¯$ ±s)	56±11	51±11	0.473	0.030	53±11	52±12	0.075	0.725
肝硬化(例)	82	22	0.255	0.307	42	19	0.118	0.864
门静脉高压(例)	49	8	0.301	0.188	20	7	0.077	0.578
Plt>50×10⁹/L (例)	107	25	0.103	0.476	53	22	0.074	1.000
PT ≤14.5 s (例)	85	21	0.069	0.756	45	19	0.108	1.000
AFP≤400 μg/L (例)	103	25	0.085	1.000	53	22	0.148	0.511
TB>17.1 μmol/L (例)	26	6	0.018	0.933	12	5	0.067	0.963
ALB>35 g/L(例)	92	25	0.599	0.207	53	22	0.148	0.511
病灶单发(例)	79	20	0.103	0.645	42	17	0.118	0.714
病灶最大径 [mm, M (Q_R)]	14 (9)	17 (10)	0.272	0.178	14 (9)	17 (10)	0.139	0.334
原发病灶(例)	33	12	0.312	0.123	21	10	0.057	0.707

表1 PSM前后两组肝癌患者消融术前基线资料比较

指标	匹配前				匹配后
指标	非血管旁组	血管旁组	SMD值	P值	非血管旁组	血管旁组	SMD值	P值
男性(例)	95	25	0.459	0.335	50	22	0.111	1.000
年龄 (岁, $x ¯$ ±s)	56±11	51±11	0.473	0.030	53±11	52±12	0.075	0.725
肝硬化(例)	82	22	0.255	0.307	42	19	0.118	0.864
门静脉高压(例)	49	8	0.301	0.188	20	7	0.077	0.578
Plt>50×10⁹/L (例)	107	25	0.103	0.476	53	22	0.074	1.000
PT ≤14.5 s (例)	85	21	0.069	0.756	45	19	0.108	1.000
AFP≤400 μg/L (例)	103	25	0.085	1.000	53	22	0.148	0.511
TB>17.1 μmol/L (例)	26	6	0.018	0.933	12	5	0.067	0.963
ALB>35 g/L(例)	92	25	0.599	0.207	53	22	0.148	0.511
病灶单发(例)	79	20	0.103	0.645	42	17	0.118	0.714
病灶最大径 [mm, M (Q_R)]	14 (9)	17 (10)	0.272	0.178	14 (9)	17 (10)	0.139	0.334
原发病灶(例)	33	12	0.312	0.123	21	10	0.057	0.707

表2 PSM前后两组肝癌患者消融术后IDM情况比较[例 (%)]

IDM	匹配前				匹配后
IDM	非血管旁组	血管旁组	χ²值	P值	非血管旁组	血管旁组	χ²值	P值
是	17 (15.6)	2 (7.7)	1.084	0.529	8 (14.8)	2 (8.7)	0.534	0.714
否	92 (84.4)	24 (92.3)			46 (85.2)	21 (91.3)	0.534	0.714

表2 PSM前后两组肝癌患者消融术后IDM情况比较[例 (%)]

IDM	匹配前				匹配后
IDM	非血管旁组	血管旁组	χ²值	P值	非血管旁组	血管旁组	χ²值	P值
是	17 (15.6)	2 (7.7)	1.084	0.529	8 (14.8)	2 (8.7)	0.534	0.714
否	92 (84.4)	24 (92.3)			46 (85.2)	21 (91.3)	0.534	0.714

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Safety and efficacy of novel microwave ablation system for perivascular and non-perivascular liver cancer

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Safety and efficacy of novel microwave ablation system for perivascular and non-perivascular liver cancer