II. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Klinikum München-Neuperlach, Städtisches Klinikum München GmbH, Munich, Germany.
United European Gastroenterol J. 2016 Aug;4(4):570-9. doi: 10.1177/2050640615621235. Epub 2016 Feb 3.
Radiofrequency ablation (RFA) is a new endoscopic palliation therapy for malignant biliary obstruction. The aim of this study was to compare the short-term effects of biliary drainage and adverse events of this technique with the standard of endoscopical treatment of hilar cholangiocarcinoma, photodynamic therapy (PDT).
We retrospectively and since December 2012 prospectively investigated the efficacy and adverse events of RFA in patients with hilar cholangiocarcinoma in two tertiary referral centers between November 2011 and January 2013. The approach of the study was prospective, but because of the large amount of retrospectively included patients, the design of the study is overall retrospective. A group of 20 patients treated with PDT between April 2005 and May 2011 served as a historical control.
Fourteen patients received 31 biliary RFAs and 20 patients received 36 PDTs. Within the RFA group, a significant decrease (p = 0.046) of the bilirubin level was seen 14 days after the first RFA (3.3 ± 3.9 (mg/dl) versus 2.3 ± 2.6 (mg/dl)). In the PDT group no significant decrease (p = 0.67) of the bilirubin level was obtained (4.1 ± 6.9 (mg/dl) versus 3.5 ± 5.3 (mg/dl)). In the PDT group (13/20, 65%) a significantly higher number of premature stent replacements (<3 months) after the first intervention was noticed in comparison with the RFA group (four of 14, 29%) (p < 0.01). Between the first and fifth procedure, post-interventional adverse events tend to occur more frequently in patients with PDT (eight of 20, 40%) than with RFA (three of 14, 21%) (p = 0.277).
Looking at the short-term effects, we conclude that RFA may present a therapeutic alternative to PDT for palliative treatment of malignant biliary obstruction because of its simple feasibility and moderate adverse event rate. To provide a definitive evaluation of the long-term effects and of overall median survival, a controlled trial with PDT must follow.
射频消融 (RFA) 是一种治疗恶性胆道梗阻的新型内镜姑息性治疗方法。本研究的目的是比较胆道引流的短期效果和该技术的不良事件与内镜治疗肝门部胆管癌的标准方法——光动力疗法 (PDT) 的差异。
我们回顾性地自 2012 年 12 月起前瞻性地研究了 2011 年 11 月至 2013 年 1 月期间两家三级转诊中心的 20 例接受 RFA 治疗的肝门部胆管癌患者的疗效和不良事件。该研究的方法是前瞻性的,但由于大量回顾性纳入的患者,因此整体设计为回顾性。2005 年 4 月至 2011 年 5 月期间接受 PDT 治疗的 20 例患者作为历史对照。
14 例患者接受了 31 次胆道 RFA,20 例患者接受了 36 次 PDT。在 RFA 组中,首次 RFA 后 14 天胆红素水平显著下降(p=0.046)(3.3±3.9(mg/dl) 比 2.3±2.6(mg/dl))。PDT 组中胆红素水平无显著下降(p=0.67)(4.1±6.9(mg/dl) 比 3.5±5.3(mg/dl))。与 RFA 组(14 例中的 4 例,29%)相比,PDT 组(20 例中的 13 例,65%)首次介入后支架过早更换(<3 个月)的比例明显更高(p<0.01)。在第一次和第五次操作之间,PDT 组(20 例中的 8 例,40%)的术后不良事件发生率高于 RFA 组(14 例中的 3 例,21%)(p=0.277)。
从短期效果来看,我们得出结论,RFA 可能是 PDT 治疗恶性胆道梗阻的一种治疗选择,因为它具有简单的可行性和适中的不良事件发生率。为了对长期效果和总体中位生存时间进行明确评估,必须进行 PDT 的对照试验。