Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer (NCT02238613) | Clinical Trial Compass
UnknownNot Applicable
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
China140 participantsStarted 2014-08
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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