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

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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.