射频消融联合胆道子镜治疗恶性胆道梗阻金属支架术后再狭窄的疗效研究

doi:10.3877/cma.j.issn.2095-7157.2026.03.004

目的

探讨射频消融联合胆道子镜治疗恶性胆道梗阻非覆膜金属支架术后再狭窄的疗效。

方法

选取河北省沧州市中心医院内镜外科2021年1月至2022年12月住院部收治的100例恶性胆道梗阻金属支架置入术后再狭窄患者为研究对象，根据治疗方案分为联合组和对照组两组，每组各50例，联合组行射频消融联合胆道子镜清理及支架再通术、对照组行常规球囊扩张及支架再通术。主要观察指标：临床成功率；次要观察指标：技术成功率、支架通畅率、不良事件发生率、围手术期指标。本研究为非随机分组的回顾性观察性研究，上述基线均衡性仅为统计学层面匹配，仍可能存在选择偏倚。

结果

与对照组比较，联合组手术时间较长、术中出血量较低，差异具有统计学意义(P<0.05)；两组性别、年龄、体质量指数、黄疸时间、Child-Pugh分级、梗阻部位及手术成功率、住院时间、肿瘤类型、支架直径、支架长度差异无统计学意义(P>0.05)；与对照组比较，联合组术后3个月(94%)、6个月(86%)的胆道通畅率升高，差异具有统计学意义(P<0.05)，两组术后1个月通畅率差异无统计学意义(P>0.05)；对照组并发症发生率为16%，联合组为4%，差异具有统计学意义(P<0.05)；对照组治疗总有效率为76%，联合组为92%，差异具有统计学意义(P<0.05)。

结论

本研究仅反映两种完整临床介入方案的真实临床效果差异，受胆道子镜、射频消融双重干预混杂影响，不能判定疗效优势仅由射频消融单独引起，射频消融联合胆道子镜直视方案在提高临床总有效率、延长胆道通畅时间方面表现更佳且不增加并发症风险，具备临床参考价值。

关键词: 恶性胆道梗阻, 术后再狭窄, 射频消融, 胆道子镜, 疗效

Objective

To explore the efficacy of radiofrequency ablation combined with biliary endoscopy in treating restenosis after metal stent implantation for malignant biliary obstruction.

Methods

A total of 100 patients with restenosis after metal stent implantation for malignant biliary obstruction admitted to the Department of Endoscopic Surgery, Cangzhou Central Hospital of Hebei Province from January 2021 to December 2022 were enrolled as research subjects.Patients were divided into combination group and control group according to treatment regimens, with 50 cases in each group.The combination group received radiofrequency ablation combined with cholangioscopy-guided debridement and stent recanalization, while the control group underwent conventional balloon dilation and stent recanalization.Observation indicators: Primary outcome: clinical success rate; Secondary outcomes: technical success rate; stent patency rate; incidence of adverse events; perioperative indicators.This is a retrospective observational non-randomized study.Baseline balance was achieved only at the statistical level, and selection bias may still exist.

Results

Compared with the control group, the operation time of the combined group was longer and the intraoperative blood loss was lower, and the difference was statistically significant (P<0.05); there were no statistically significant differences in gender, age, body mass index, jaundice duration, Child-Pugh classification, obstruction site, surgical success rate, hospital stay, tumor type, stent diameter, and stent length between the two groups (P>0.05); Compared with the control group, the biliary tract patency rate at 3 months (94%) and 6 months (86%) after surgery in the combined group increased, and the difference was statistically significant (P<0.05), while the patency rate at 1 month after surgery was not statistically significant between the two groups (P>0.05); The complication rate of the control group was 16%, and that of the combined group was 4%, and the difference was statistically significant (P<0.05); The total effective rate of treatment in the control group was 76%, and that in the combined group was 92%, and the difference was statistically significant (P<0.05).

Conclusion

This study only reflects the true clinical effect differences between the two complete clinical intervention schemes.Due to the confounding effect of the dual intervention of biliary endoscopy and radiofrequency ablation, it cannot be determined that the therapeutic advantage is solely caused by radiofrequency ablation alone.The combined radiofrequency ablation and biliary endoscopy direct vision scheme performs better in increasing the overall clinical effectiveness rate and prolonging the biliary patency time, and does not increase the risk of complications, and thus has clinical reference value.

Key words: Malignant biliary obstruction, Postoperative restenosis, Radio frequency ablation, Biliary endoscope, Therapeutic effect

图1 病例筛选流程图

图2 射频消融联合胆道子镜清理及支架再通术治疗注：A：胆管插管成功后造影，胆总管中下段金属支架内未显影；B：置入胆道子镜观察胆管内珊瑚样组织增生，管腔狭窄；C：沿导丝置入射频导管，透视下定位于狭窄处；D：射频消融后，应用取石球囊导管清理胆道，可见灰白色坏死组织被球囊拖出；E：清理后置入胆道子镜观察，胆管增生组织呈灰白色改变，消融满意；F：再次球囊造影显示原未显影狭窄处已显影，管腔狭窄改善

表1 对照组与联合组患者临床病理特征及围手术期指标比较[例(%)]

组别	性别		年龄(岁，±s)	体质量指数(kg/m²，±s)	黄疸时间(d，±s)
组别	男	女	年龄(岁，±s)	体质量指数(kg/m²，±s)	黄疸时间(d，±s)
对照组(n＝50)	22(44)	28(56)	61.75±5.20	24.56±4.12	14.59±3.30
联合组(n＝50)	21(42)	29(58)	60.59±5.10	24.61±4.08	14.23±3.15
统计值	χ²＝0.041		t＝1.126	t＝0.061	t＝0.558
P值	0.840		0.263	0.952	0.578
组别	Child-Pugh分级			梗阻部位
组别	A级	B级	C级	左右肝管汇合处	肝总管	胆总管中段	胆总管下段
对照组(n＝50)	29(58)	15(30)	6(12)	16(32)	12(24)	6(12)	16(32)
联合组(n＝50)	27(54)	16(32)	7(14)	15(30)	13(26)	7(14)	15(30)
]χ²值	0.162			0.047
P值	0.687			0.829
组别	手术成功率	手术时间[M(Q₁，Q₃)，min]	术中出血量[M(Q₁，Q₃)，ml]	住院时间[M(Q₁，Q₃，d]
对照组(n＝50)	48(96)	65[60，72]	50[45, 55]	7.50 [6, 9]
联合组(n＝50)	50(100)	90[85，98]	45[40, 50]	7 [6, 8]
统计值	χ²＝2.041	U＝12.569	U＝3.356	U＝0.725
P值	0.153	<0.001	0.004	0.359
组别	肿瘤类型				支架直径(mm，±s)	支架长度(mm，±s)
组别	肝外胆管癌	胰头癌	壶腹周围癌	转移性淋巴结压迫	支架直径(mm，±s)	支架长度(mm，±s)
对照组(n＝50)	18(36)	15(30)	9(18)	3(6)	9.52±0.86	74.80±13.28
联合组(n＝50)	17(34)	16(32)	8(16)	6(12)	9.60±0.81	74.00±11.61
统计值	χ²＝0.044				t＝0.633	t＝0.749
P值	0.834				0.478	0.321

表1 对照组与联合组患者临床病理特征及围手术期指标比较[例(%)]

组别	性别		年龄(岁，±s)	体质量指数(kg/m²，±s)	黄疸时间(d，±s)
组别	男	女	年龄(岁，±s)	体质量指数(kg/m²，±s)	黄疸时间(d，±s)
对照组(n＝50)	22(44)	28(56)	61.75±5.20	24.56±4.12	14.59±3.30
联合组(n＝50)	21(42)	29(58)	60.59±5.10	24.61±4.08	14.23±3.15
统计值	χ²＝0.041		t＝1.126	t＝0.061	t＝0.558
P值	0.840		0.263	0.952	0.578
组别	Child-Pugh分级			梗阻部位
组别	A级	B级	C级	左右肝管汇合处	肝总管	胆总管中段	胆总管下段
对照组(n＝50)	29(58)	15(30)	6(12)	16(32)	12(24)	6(12)	16(32)
联合组(n＝50)	27(54)	16(32)	7(14)	15(30)	13(26)	7(14)	15(30)
]χ²值	0.162			0.047
P值	0.687			0.829
组别	手术成功率	手术时间[M(Q₁，Q₃)，min]	术中出血量[M(Q₁，Q₃)，ml]	住院时间[M(Q₁，Q₃，d]
对照组(n＝50)	48(96)	65[60，72]	50[45, 55]	7.50 [6, 9]
联合组(n＝50)	50(100)	90[85，98]	45[40, 50]	7 [6, 8]
统计值	χ²＝2.041	U＝12.569	U＝3.356	U＝0.725
P值	0.153	<0.001	0.004	0.359
组别	肿瘤类型				支架直径(mm，±s)	支架长度(mm，±s)
组别	肝外胆管癌	胰头癌	壶腹周围癌	转移性淋巴结压迫	支架直径(mm，±s)	支架长度(mm，±s)
对照组(n＝50)	18(36)	15(30)	9(18)	3(6)	9.52±0.86	74.80±13.28
联合组(n＝50)	17(34)	16(32)	8(16)	6(12)	9.60±0.81	74.00±11.61
统计值	χ²＝0.044				t＝0.633	t＝0.749
P值	0.834				0.478	0.321

表2 对照组与联合组患者术后胆道通畅情况[例(%)]

组别	术后1个月通畅率	术后3个月通畅率	术后6个月通畅率
对照组(n＝50)	48(96)	36(72)	30(60)
联合组(n＝50)	49(98)	47(94)	43(86)
χ²值	0.344	8.575	8.574
P值	0.558	0.003	0.003

表2 对照组与联合组患者术后胆道通畅情况[例(%)]

组别	术后1个月通畅率	术后3个月通畅率	术后6个月通畅率
对照组(n＝50)	48(96)	36(72)	30(60)
联合组(n＝50)	49(98)	47(94)	43(86)
χ²值	0.344	8.575	8.574
P值	0.558	0.003	0.003

表3 对照组与联合组患者并发症发生情况比较[例(%)]

组别	疼痛	胆道出血	呕吐	胆漏	术后胆管炎	总计
对照组(n＝50)	5(10)	1(2)	2(4)	0(0)	0(0)	8(16)
联合组(n＝50)	1(2)	0(0)	1(2)	0(0)	0(0)	2(4)
χ²值						4.000
P值						0.046

表3 对照组与联合组患者并发症发生情况比较[例(%)]

组别	疼痛	胆道出血	呕吐	胆漏	术后胆管炎	总计
对照组(n＝50)	5(10)	1(2)	2(4)	0(0)	0(0)	8(16)
联合组(n＝50)	1(2)	0(0)	1(2)	0(0)	0(0)	2(4)
χ²值						4.000
P值						0.046

表4 对照组与联合组患者临床疗效比较[例(%)]

组别	显效	有效	无效	总有效率
对照组(n＝50)	20(40)	18(36)	12(24)	38(76)
联合组(n＝50)	26(52)	20(40)	4(8)	46(92)
χ²值				4.762
P值				0.029

表4 对照组与联合组患者临床疗效比较[例(%)]

组别	显效	有效	无效	总有效率
对照组(n＝50)	20(40)	18(36)	12(24)	38(76)
联合组(n＝50)	26(52)	20(40)	4(8)	46(92)
χ²值				4.762
P值				0.029

图3 对照组与联合组患者生存曲线对比

[1]	吕毅，刘龙，徐庶钦．磁外科技术在消化道疾病中的创新应用进展[J]. 中华消化外科杂志，2025，24(4)：452-458.
[2]	Hasegawa S，Sato T，Shinoda S，et al.Braided-type stent versus laser-cut-type stent for patients with unresectable distal malignant biliary obstruction: a randomized controlled trial[J].Gastrointest Endosc，2024, 99(5)：739-746.e1.
[3]	Hedjoudje A，Pokossy Epée J，Perez-Cuadrado-Robles E，et al.Long- term outcomes of endoscopic ultrasound-guided hepaticogastrostomy in patients with malignant biliary obstruction[J].United European Gastroenterol J，2024，12(8)：1044-1055.
[4]	Faisal MS，Hasso M，Saleem A，et al.Biliary Radiofrequency Ablation and Sphincterotomy Restenosis：A Unique Case of Biliary Obstruction[J]. ACG Case Rep J，2025，12(9)：e01824.
[5]	Ban T，Kubota Y，Sasoh S，et al.Gel-immersion biliary cannulation during a balloon-assisted endoscope-guided endoscopic retrograde cholangiopancreatography[J].Endoscopy，2025，57(Suppl 1)：E329-E330.
[6]	国家消化内镜专业质控中心，国家消化系统疾病临床医学研究中心(上海)，国家消化道早癌防治中心联盟，等．中国消化道疾病内镜下射频消融术临床应用专家共识(2020，上海)[J].中华消化内镜杂志，2020, 37(2)：77-82.
[7]	Fiedler A，Dhindsa B，Bhat I，et al.Using the Rendezvous Technique Through Choledochoduodenostomy for Malignant Biliary Obstruction[J]. ACG Case Rep J，2024，11(6)：e01370.
[8]	Lee J，Jeong S，Lee DH，et al.Endoscopic Stenting of a Fully Covered Self-Expandable Metal Stent with a Hole in Each Cavity in Malignant Hilar Biliary Obstruction：A Preclinical Proof-of-Concept Study and Initial Human Experience[J].Dig Dis Sci，2025，70(3)：1215-1222.
[9]	郭思捷，王宏光，陶丽莹，等．一次性子母胆道镜辅助内镜逆行阑尾炎治疗术对急性非复杂性阑尾炎的诊断和治疗价值分析[J].中国内镜杂志，2025，31(11)：55-61.
[10]	Altonbary A，Hakim H，Elrabat A，et al.Endoscope traction technique to facilitate over-the-wire biliary cannulation during EUS-guided rendezvous[J].Video GIE，2024，9(10)：446-448.
[11]	王馨祎，王林恒，高霞，等．内镜下胆道射频消融联合支架植入治疗恶性胆道梗阻的疗效及安全性分析[J].胃肠病学和肝病学杂志，2024, 33(11)：1530-1534.
[12]	Tzedakis S，Belle A，Berzan D，et al.Preoperative Endoscopic Ultrasound-Guided Hepaticogastrostomy for Definite Biliary Drainage in Hilar Cholangiocarcinoma Laparoscopic Resection：A Hybrid Minimal- Invasive Technique[J].Surg Innov，2024，31(1)：11-15.
[13]	Emori T，Itonaga M，Ashida R，et al.Impact of sarcopenia on recurrent biliary obstruction after EUS-guided biliary drainage in patients with malignant biliary obstruction[J].Int J Clin Oncol，2024，29(3)：286-296.
[14]	樊志旭，侯波．射频消融术治疗恶性胆道梗阻的研究进展[J].现代消化及介入诊疗，2024，29(1)：96-100.
[15]	Mundhava M，Vadodariya B，Jangid P，et al.Histotripsy Compared With Microwave Ablation, Radiofrequency Ablation，and Stereotactic Body Radiotherapy for the Treatment of Liver Tumors[J].Cureus，2025, 17(12)：e100088.
[16]	Klimczak T，Smigielski J．Direct peroral cholangioscopy combined with argon plasma and radio-frequency ablation in restoring the patency of a self-expandable metal stent[J].Prz Gastroenterol，2024，16(4)：460-462.
[17]	Yamada M，Okamoto T，Sasahira N，et al.Troubleshooting with a drill dilator for the stent-in-stent technique in malignant hilar biliary obstruction[J].Endoscopy，2023，55(S 1)：E189-E190.
[18]	Zhang S，Huang S，Xing Z，et al.Clinical effect of percutaneous hepatic puncture biliary drainage combined with metal stent implantation in the treatment of malignant obstructive jaundice[J].BMC Surg, 2025，25(1)：126.
[19]	Liu C，Dong J，Liu Y，et al.Is endoscopic radiofrequency ablation plus stent placement superior to stent placement alone for the treatment of malignant biliary obstruction? A systematic review and meta-analysis[J]. J Int Med Res，2023，51(12)：3000605231220825.
[20]	Inoue T，Naitoh I．Updates on Endoscopic Stenting for Unresectable Malignant Hilar Biliary Obstruction[J].J Clin Med，2024，13(18)：5410.
[21]	Bergen JL，Travis BM，Pike FS，et al.Clinical use of uncovered balloon-expandable metallic biliary stents for treatment of extrahepatic biliary tract obstructions in cats and dogs：11 cases (2012-2022)[J].Vet Surg，2024，53(2)：320-329.
[22]	Inoue T，Ibusuki M，Kitano R，et al.Double bare metal stent deployment combined with intraductal radiofrequency ablation for malignant distal biliary obstruction：a prospective pilot study[J].Sci Rep，2023，13(1)：2654.

[1]	于世元, 邓嘉诚, 王磊, 孙旭, 李朦, 李响, 张熠, 史若彤, 吕铮. 3种细胞周期蛋白依赖性激酶4/6抑制剂在激素受体阳性/HER-2阴性乳腺癌中的疗效和安全性分析[J/OL]. 中华乳腺病杂志(电子版), 2026, 20(04): 219-227.
[2]	李友, 唐林峰, 杜伟伟, 刘海亮, 巨积辉, 王东林. 双骨隧道重建止点治疗手指近指间关节掌板撕脱性损伤的临床疗效[J/OL]. 中华损伤与修复杂志(电子版), 2026, 21(04): 266-270.
[3]	魏利敏, 金鲜珍, 刘萍, 王光辉. 两种微创术式治疗低位直肠癌的学习曲线与近期疗效分析[J/OL]. 中华普外科手术学杂志(电子版), 2026, 20(03): 261-266.
[4]	周哲琦, 艾克拜尔·艾力, 李义亮, 麦麦提艾力·麦麦提明, 玉素江·图荪托合提, 克力木·阿不都热依木. 机器人辅助与腹腔镜袖状胃切除联合胃底折叠及食管裂孔疝修补术的临床疗效[J/OL]. 中华疝和腹壁外科杂志(电子版), 2026, 20(03): 259-264.
[5]	李文芳, 董孟炜, 杨万彭, 巴特, 南楠, 刘杨, 郝慧琴. 关节腔注射脂肪间充质干细胞对碘乙酸钠诱导大鼠急性软骨损伤的抗炎及组织学修复作用[J/OL]. 中华细胞与干细胞杂志(电子版), 2026, 16(05): 266-277.
[6]	成津, 郭建明. 间充质干细胞治疗糖尿病足溃疡的研究现状与进展[J/OL]. 中华细胞与干细胞杂志(电子版), 2026, 16(05): 278-284.
[7]	汪韬, 潘炳权, 郁林海. 经脐入路三通道腹腔镜胆囊切除术的安全性与疗效分析：附10 000例报告[J/OL]. 中华肝脏外科手术学电子杂志, 2026, 15(05): 791-797.
[8]	李海波, 李洋, 曾涛, 冯程, 李华. 基于3期RCT中国人群数据的肝细胞癌一线治疗方案网状Meta分析[J/OL]. 中华肝脏外科手术学电子杂志, 2026, 15(04): 558-567.
[9]	韩晓钊, 杨能红, 韩民, 李永宁, 冉勋, 张宏, 何志伟, 罗加农, 喻超. 机器人与腹腔镜保留脾脏胰体尾切除术安全性及疗效比较[J/OL]. 中华肝脏外科手术学电子杂志, 2026, 15(04): 568-574.
[10]	陈丽君, 黎建绪, 梁世雄, 向邦德. 原发性肝癌放疗策略与应用展望[J/OL]. 中华肝脏外科手术学电子杂志, 2026, 15(03): 299-306.
[11]	吴杰嵘, 严庆, 胡健垣, 陈焕伟. 复发性肝细胞癌再次手术切除与射频消融临床疗效比较[J/OL]. 中华肝脏外科手术学电子杂志, 2026, 15(02): 211-218.
[12]	杜修琪, 侍新宇, 胡优, 王索, 孙金兵, 钟润泽, 柯子昂, 王梦婷, 穆丽茜, 张丽娟, 周晓俊, 何宋兵. 机器人单切口加一孔与腹腔镜多孔全结肠切除术治疗慢传输型便秘的短期疗效比较[J/OL]. 中华结直肠疾病电子杂志, 2026, 15(04): 340-348.
[13]	李鹏, 冯文博, 王延成, 张佩, 马红霞. 超选择血管介入联合髓芯减压植骨术治疗股骨头缺血性坏死的疗效及对术后并发症的影响[J/OL]. 中华老年骨科与康复电子杂志, 2026, 12(04): 236-242.
[14]	宋宏伟, 张宇, 张珊珊. 四逆散联合西医治疗老年难治性胃食管反流病肝胃不和证患者的疗效及对细胞因子的影响研究[J/OL]. 中华消化病与影像杂志(电子版), 2026, 16(05): 452-456.
[15]	张婧萱, 郭佳星, 李紫红, 陈怡颖, 乔媛, 宝莹娜. 多线治疗失败后31例复发转移性结直肠癌局部挽救性放射治疗的研究[J/OL]. 中华消化病与影像杂志(电子版), 2026, 16(03): 206-211.

阅读次数

全文

摘要

选择文件类型/文献管理软件名称

选择包含的内容

Study on the efficacy of radiofrequency ablation combined with choledochoscopy in the treatment of restenosis after metal stent implantation for malignant biliary obstruction

模态框（Modal）标题

选择文件类型/文献管理软件名称

选择包含的内容

Study on the efficacy of radiofrequency ablation combined with choledochoscopy in the treatment of restenosis after metal stent implantation for malignant biliary obstruction