A clinical trial assessing the feasibility, efficacy, and safety of a personalized radiofrequency ablation protocol together with complete biliary drainage in patients with perihilar cholangiocarcinoma that cannot be treated with surgery is now recruiting participants in Romania.

The trial, sponsored by Clinical Hospital Colentina in Bucharest, Romania, aims to recruit 30 participants, 18 years of age and older, with unresectable perihilar cholangiocarcinoma whose disease is limited to 1 site. Patients who have surgically altered anatomy or a life expectancy of less than 3 months are not eligible to take part. 

Patients will be randomized to 1 of 2 study arms. Those in the first arm will undergo biliary stenting only, while those in the second arm will undergo endoluminal radiofrequency ablation before biliary stenting.


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The primary outcome measures of the study are the technical success of the endoscopic retrograde cholangiopancreatography procedure, the ability to correctly apply radiofrequency ablation and place stents in all the biliary ducts, and tumor response as assessed by the Response Evaluation Criteria in Solid Tumours (RECIST) criteria at 6 months.

The secondary outcome measures are the rate of procedure-related adverse events such as cholangitis, bleeding, perforation, and pancreatitis after the procedure, and overall survival at 12 months. 

The trial started on August 1, 2022, and is expected to be completed on December 31, 2024. More information can be found on the trial’s website

Cholangiocarcinoma is a heterogeneous group of rare malignant tumors originating from the cells of the biliary tree. There are 3 subtypes of cholangiocarcinoma based on the anatomical origin of the tumor. These are intrahepatic, perihilar, and distal cholangiocarcinoma. 

The treatment of the disease typically involves surgical intervention followed by adjuvant therapies. However, almost half of patients have unresectable disease due to late diagnosis. In these patients, hepatic parenchyma drainage may increase survival. 

Reference

Endoscopy and radiology-guided ablation for inoperable cholangiocarcinoma (COMBO-RFA). US National Library of Medicine. Last updated October 3, 2022. Accessed October 6, 2022.