Ampullary Carcinoma, Biliary Obstruction, Cholangiocarcinoma of the Extrahepatic Bile Duct, Intrahepatic Cholangiocarcinoma
Conditions
Keywords
Radioactive stents, Brachytherapy, Biliary obstruction, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, ampullary carcinoma
Brief summary
The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.
Detailed description
Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.
Interventions
DEVICEradioactive stent
radioactive stent carrying seed iodine 125
DEVICEplastic stent
common plastic stent without carrying seed iodine 125
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Changhai Hospital
307 Hospital of PLA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma) * Patients aged between 18 and 80 years * an estimated life expectancy of more than 3 months * Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria * TNM stage III-IV * no evidence of cancer of another organ. * no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed * Karnofsky index of ≥60% * ECOG index ≥2 * previous technically successful stenting or ENBD derange * Accept of informed consent
Exclusion criteria
* Clinically significant cardiovascular disease * coagulation disorders * contraindication of Endoscopic * pregnant or breastfeeding women * known sensitivity sensitivity to investigated agents or components * recent invasive procedure * prior chemotherapy or radiotherapy for biliary cancer * refusal of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response rate | 3 months | The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 6 months | In order to research the progression-free survival, the investigators will check the presence of progression disease for each patients until the date of disease progression or death. |
| overall survival | follow-up in interval of stent insertion and death (1 years) | Overall survival was calculated from the date of randomization until the date of death. |
| Adverse events | 1 year | Individual adverse events |
Countries
China
Contacts
Primary ContactYan Liu, MD,PhD
Outcome results
None listed