辅助性胆管内射频消融联合自膨式金属胆道支架治疗不可切除的恶性肝门部狭窄：一项实用性比较研究。
Adjuvant endobiliary radio-frequency ablation combined with self-expandable biliary metal stents for unresectable malignant hilar strictures: A pragmatic comparative study.
作者信息
Jagtap Nitin, Kumar C Sai, Lakhtakia Sundeep, Ramchandani Mohan, Memon Sana Fathima, Asif Shujaath, Kalapala Rakesh, Nabi Zaheer, Basha Jahangeer, Gupta Rajesh, Tandan Manu, Reddy D Nageshwar
机构信息
Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
出版信息
Indian J Gastroenterol. 2025 Feb;44(1):72-79. doi: 10.1007/s12664-024-01668-1. Epub 2024 Sep 6.
INTRODUCTION
The role of endo-biliary radio-frequency ablation (EB-RFA) in treating malignant biliary strictures remains a subject of controversy. This study aims to assess the efficacy and safety of EB-RFA in conjunction with self-expandable metal stents (SEMS) compared to SEMS alone.
METHODS
This single-center prospective pragmatic comparative study, conducted between June 2021 and November 2022, involved 23 patients undergoing EB-RFA plus SEMS and 48 patients undergoing SEMS for unresectable malignant hilar obstruction. The study evaluated overall survival, stent patency and adverse events.
RESULTS
Seventy-one patients (mean age [SD], 57.8 [11.2] years; 73.2% men) were enrolled. The clinical success rates did not significantly differ between the two groups (78.3% in EB-RFA and 66.6% in SEMS; p 0.316). The median (95% CI) overall survival was 155 (79.87-230.13) days in the EB-RFA group, contrasting with 86.0 (78.06-123.94) days in the SEMS group (p 0.020). The presence of carcinoma gallbladder (p 0.035; HR 0.55; 95% CI 0.32-0.96) and EB-RFA (p 0.047; HR 1.88; 95% CI 1.01-3.49) independently predicted overall survival. Median (95% CI) stent patency was 143.0 (95% CI, 61.61-224.39) days in the EB-RFA group compared to 78.0 (95% CI, 32.74-123.26) days in the SEMS group (p 0.019). The presence of carcinoma gallbladder (p 0.046, HR 0.60; 95% CI, 0.36-0.99), EB-RFA (p 0.023; HR 1.92; 95% CI, 1.10-3.36) and chemotherapy (p 0.017, HR 1.91; 95% CI, 1.12-3.26) independently predicted longer stent patency. There was no difference in procedure-related adverse events in both groups.
CONCLUSION
EB-RFA with SEMS placement proves to be a safe and effective technique for palliative biliary decompression in patients with malignant biliary strictures, demonstrating superior overall survival and stent patency compared to SEMS alone. Further confirmation through multi-center trials is warranted.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov (ID: NCT05320328).
引言
胆管内射频消融术（EB-RFA）在治疗恶性胆管狭窄中的作用仍存在争议。本研究旨在评估与单纯自膨式金属支架（SEMS）相比，EB-RFA联合SEMS的疗效和安全性。
方法
这项单中心前瞻性实用比较研究于2021年6月至2022年11月进行，纳入了23例行EB-RFA联合SEMS和48例行SEMS治疗不可切除恶性肝门部梗阻的患者。该研究评估了总生存期、支架通畅率和不良事件。
结果
共纳入71例患者（平均年龄[标准差]，57.8[11.2]岁；73.2%为男性）。两组的临床成功率无显著差异（EB-RFA组为78.3%，SEMS组为66.6%；p = 0.316）。EB-RFA组的中位（95%CI）总生存期为155（79.87 - 230.13）天，而SEMS组为86.0（78.06 - 123.94）天（p = 0.020）。胆囊癌的存在（p = 0.035；HR = 0.55；95%CI 0.32 - 0.96）和EB-RFA（p = 0.047；HR = 1.88；95%CI 1.01 - 3.49）独立预测总生存期。EB-RFA组的中位（95%CI）支架通畅时间为143.0（95%CI，61.61 - 224.39）天，而SEMS组为78.0（95%CI，32.74 - 123.26）天（p = 0.019）。胆囊癌的存在（p = 0.046，HR = 0.60；95%CI，0.36 - 0.99）、EB-RFA（p = 0.023；HR = 1.92；95%CI，1.10 - 3.36）和化疗（p = 0.017，HR = 1.91；95%CI，1.12 - 3.26）独立预测更长的支架通畅时间。两组与手术相关的不良事件无差异。
结论
放置SEMS的EB-RFA被证明是一种用于恶性胆管狭窄患者姑息性胆管减压的安全有效的技术，与单纯SEMS相比，总生存期和支架通畅率更优。有必要通过多中心试验进一步证实。
临床试验注册
ClinicalTrials.gov（ID：NCT05320328）
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