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Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
Conditions
Intrahepatic Cholangiocarcinoma - Cholangiocarcinoma of the Extrahepatic Bile Duct - Ampullary Carcinoma - Biliary Obstruction
Conditions: official terms
Cholangiocarcinoma - Liver Neoplasms
Conditions: Keywords
Radioactive stents, Brachytherapy, Biliary obstruction, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, ampullary carcinoma
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: radioactive stent
Type: Device
Name: plastic stent
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
307 hospital of PLA
Beijing, Beijing, China
Status: Recruiting
Contact: Zhaoshen Li, Doctor
Start Date
August 2014
Completion Date
June 2017
Sponsors
307 Hospital of PLA
Source
307 Hospital of PLA
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page