An interventional study of radiofrequency ablation and Chemotherapy drug in Cholangiocarcinoma, sponsored by First People's Hospital of Hangzhou. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by First People's Hospital of Hangzhou · Not applicable, Interventional, and Treatment
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.
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
914 studies on the registry are indexed under Cholangiocarcinoma; 285 are open to participants now.
This study's enrollment of 70 is above the median of 50 across 686 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →First People's Hospital of Hangzhou is the lead sponsor of 70 studies on the registry; 26 are open to participants now.
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Exclusion Criteria
Patients will receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement, and be treated with gemcitabine and S-1 within 1 month after RFA.
Device: radiofrequency ablation · Drug: Chemotherapy drug
Patients will only receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement
Device: radiofrequency ablation
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
Also known as: oral fluoropyrimidine
survival time
The period from endoscopic treatment to patient death or the last day of study
Time frame: two years
Adverse events
Number of participants with adverse events; type, frequency and intensity of adverse events
Time frame: one month
Stent patency time
Take the stent placement as the starting point and the stent occlusion confirmed by ERCP as the end point. Record the time interval between the two point
Time frame: two years
Progression free survival
evaluate the survival time without disease progression
Time frame: two years
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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First People's Hospital of Hangzhou