Endobiliary Radiofrequency Ablation With S-1 for Unresectable Cholangiocarcinoma

Endobiliary Radiofrequency Ablation With S-1 in Patients With Unresectable Cholangiocarcinoma: A Prospective Randomized Trial With Open Label Control

Endobiliary radiofrequency ablation (RFA) with biliary stent has been reported to be a beneficial treatment option for palliation of malignant biliary strictures. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased tumor ingrowth. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to evaluate the combined effect of RFA and S-1 in patients with unresectable cholangiocarcinoma.

Over 60 % of common bile duct (CBD) obstructions are due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis. Biliary drainage with placement of metal or plastic stents for palliation is the therapy of choice in this set of patients.

Radiofrequency ablation (RFA) is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Many studies showed RFA with biliary stent was a beneficial treatment option for palliation of malignant biliary strictures. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma.

The aim of this study is to conduct a randomised, controlled, clinical trial to compare the effect of S-1 plus RFA with stent with RFA with stent in patients with unresectable cholangiocarcinoma.

Inclusion Criteria:

• Obtention of a written informed consent.
• Patient over 18.
• Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA.
• Patient with Karnofsky score ≥ 50 %
• Patient capable of fill in the quality of life questionnaire.

Exclusion Criteria:

• No written informed consent.
• Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
• Patients with porphyria or hypersensibility to porphyrins.
• Pregnant, parturient or breastfeeding women.
• Patient under 18.