Radiofrequency ablation via catheter and transpapillary access in patients with cholangiocarcinoma (ACTICCA-2)

通过导管和经乳头入路对胆管癌患者进行射频消融 (ACTICCA-2)

• 批准号: 432667587
• 负责人: Professor Dr. Henning Wege
• 金额: --
• 依托单位: I. Medizinische Klinik und Poliklinik
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/432667587?language=en
• 关键词: Radiofrequency; ablation; via; catheter; transpapillary

Biliary tract cancer (cholangiocarcinoma, CCA) frequently results in bile duct obstruction (cholestasis with jaundice), a situation associated with high risk for bacterial infections (cholangitis) and interruption of the life-prolonging systemic therapy (chemotherapy). Patients with obstructed bile ducts therefore receive endoscopically placed plastic or metal stents. The ACTICCA-2 study evaluates whether additional radiofrequency ablation in obstructed bile ducts, i.e. thermal destruction of the luminal tumor, in addition to stent placement reduces the rate of stent dysfunction and chemotherapy disruption. At the participating eleven university centers, patients will be randomized (1:1) to receive stents and chemotherapy (control arm) or radiofrequency ablation, stents, and chemotherapy (study arm). We will randomize 120 patients to demonstrate a statistically significant and clinically relevant prolongation in the time to stent dysfunction (clinically evident by fever and elevated liver function tests indicating bacterial infection and/or cholestasis). Endoscopic radiofrequency ablation will be performed with a CE-certified catheter. Based on retrospective case series, security concerns have been raised using the catheter. To this regard, the randomized ACTICCA-2 study will also prospectively investigate the safety of endoscopic radiofrequency ablation. In summary, the ACTICCA-2 study will answer safety and efficacy issues related to additional intraductal radiofrequency ablation in patients with biliary tract cancer and indication for stent placement and chemotherapy. Thus, the study will define future treatment standards in patients with biliary tract cancer.

胆道癌（胆管癌，CCA）经常导致胆管阻塞（胆汁淤积伴黄疸），这种情况与细菌感染（胆管炎）的高风险和延长生命的全身治疗（化疗）的中断有关。因此，胆管阻塞的患者接受内窥镜下放置的塑料或金属支架。ACTICCA-2研究评价了在阻塞胆管中进行额外射频消融（即，管腔肿瘤的热破坏）以及支架置入是否可降低支架功能障碍和化疗中断的发生率。在参与的11个大学中心，患者将随机（1：1）接受支架和化疗（对照组）或射频消融、支架和化疗（研究组）。我们将对120例患者进行随机分组，以证明支架功能障碍时间的统计学显著性和临床相关性延长（临床表现为发热和肝功能检查升高，表明细菌感染和/或胆汁淤积）。将使用CE认证的导管进行内镜射频消融。基于回顾性病例系列，使用该导管引起了安全性问题。在这方面，随机化ACTICCA-2研究也将前瞻性研究内镜射频消融的安全性。总之，ACTICCA-2研究将回答与胆道癌患者额外导管内射频消融相关的安全性和有效性问题以及支架置入和化疗的适应症。因此，该研究将确定胆道癌患者未来的治疗标准。