Status:
UNKNOWN
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
Lead Sponsor:
307 Hospital of PLA
Collaborating Sponsors:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Changhai Hospital
Conditions:
Intrahepatic Cholangiocarcinoma
Cholangiocarcinoma of the Extrahepatic Bile Duct
Eligibility:
All Genders
18-80 years
Phase:
NA
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 (irradiati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2017
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT02238613
Start Date
August 1 2014
End Date
June 1 2017
Last Update
September 12 2014
Active Locations (1)
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1
307 hospital of PLA
Beijing, Beijing Municipality, China, 10086