RFA Combined With Chemotherapy for Unresectable Cholangiocarcinoma
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Study type: Interventional

Summary: 
      Extrahepatic cholangiocarcinoma is a malignant tumor that is highly malignant and difficult
      to diagnose and treat early. Endobiliary radiofrequency ablation (RFA) has been reported to
      be a beneficial treatment option for palliation of malignant biliary strictures. Within the
      bile duct, RFA appears to be safe and may result in decreased tumor ingrowth. 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 compare the efficacy and safety of RAF
      combined with Gemcitabine and S-1 in patients with unresectable cholangiocarcinoma.
    

Detailed description: 
      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 compare the efficacy and safety of RAF combined with Gemcitabine
      and S-1 in patients with unresectable cholangiocarcinoma
    

Intervention name(s): radiofrequency ablation; Chemotherapy drug
Intervention type(s): Device; Drug
Intervention description(s): All patients underwent biliary sphincterotomy. Cholangiogram was performed to confirm stricture location, length and diameter. The Habib Endo HPB (Hepatobiliary) probe (EMcision, HitchinHerts, UK) was then advanced over a wire at the level of the biliary stricture and ablation using ERBE generator set at 7-10 watts for a time period of 90-120 s was conducted. A 1- to 2-min resting period after energy delivery was allowed before moving the catheter along the length of the stricture to ablate the rest of the stricture. Plastic stent(s) were placed after RFA depending on the location of the malignant obstruction; Gemcitabine 1 000 mg/m2 intravenously on day 1，8; S-1 80 mg/m2 was taken orally twice for two weeks. The curative effect was evaluated comprehensively for each 2 cycles of chemotherapy
Other intervention name(s): oral fluoropyrimidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: biliary tract cancer; radiofrequency ablation; S-1; Gemcitabine