Cholangiocarcinoma
Conditions
Keywords
biliary tract cancer, radiofrequency ablation, S-1, Gemcitabine
Brief 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
Interventions
DEVICEradiofrequency 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
DRUGChemotherapy drug
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
Sponsors
Hangzhou Cancer Hospital
Changhai Hospital
Eastern Hepatobiliary Surgery Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Xijing Hospital
First People's Hospital of Hangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Obtention of a written informed consent. * 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 \> 60， ECOG\>level 2 * Patient capable of fill in the quality of life questionnaire * For the first time treatment * CT, MRCP, EUS and other examinations indicate that the tumor has locally infiltrated large blood vessels and cannot be surgically removed
Exclusion criteria
* No written informed consent * Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma. * Pregnant, parturient or breastfeeding women * Serious abnormalities in liver and kidney function and coagulation function * The ERCP guide wire cannot pass the stricture due to severe biliary stricture * Merge with other malignant tumors * Use other treatments that may affect the observation, such as radioactive particles or seed stent implantation, P53 injection, oral chemotherapy, interventional therapy, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| survival time | two years | The period from endoscopic treatment to patient death or the last day of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | one month | Number of participants with adverse events; type, frequency and intensity of adverse events |
| Stent patency time | two years | 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 |
| Progression free survival | two years | evaluate the survival time without disease progression |
Countries
China
Outcome results
None listed