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Trial Title:
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
NCT ID:
NCT02238613
Condition:
Intrahepatic Cholangiocarcinoma
Cholangiocarcinoma of the Extrahepatic Bile Duct
Ampullary Carcinoma
Biliary Obstruction
Conditions: Official terms:
Cholangiocarcinoma
Biliary Tract 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
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
radioactive stent
Description:
radioactive stent carrying seed iodine 125
Arm group label:
radioactive stent
Other name:
brand names: carriable radioactive bile duct plastic stent
Other name:
serial numbers and code name: PBS1-A/B-10/160/140
Intervention type:
Device
Intervention name:
plastic stent
Description:
common plastic stent without carrying seed iodine 125
Arm group label:
plastic stent
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
307 hospital of PLA
Address:
City:
Beijing
Zip:
10086
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaoshen Li, Doctor
Investigator:
Last name:
Min Min, M.D. PhD.
Email:
Sub-Investigator
Start date:
August 2014
Completion date:
June 2017
Lead sponsor:
Agency:
307 Hospital of PLA
Agency class:
Other
Collaborator:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Collaborator:
Agency:
Changhai Hospital
Agency class:
Other
Source:
307 Hospital of PLA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02238613
