Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
NCT ID: NCT02238613
Last Updated: 2014-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2014-08-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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radioactive stent
The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients.
radioactive stent
radioactive stent carrying seed iodine 125
plastic stent
The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients.
plastic stent
common plastic stent without carrying seed iodine 125
Interventions
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radioactive stent
radioactive stent carrying seed iodine 125
plastic stent
common plastic stent without carrying seed iodine 125
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Changhai Hospital
OTHER
307 Hospital of PLA
OTHER
Responsible Party
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yan liu
PhD, MD. Chairman of Department of Gastroenterology and Hepatology, 307 Hospital of PLA
Principal Investigators
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Yan Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
307 hospital of PLA, Beijing, China
Locations
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307 hospital of PLA
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhaoshen Li, Doctor
Role: primary
Other Identifiers
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307xhk
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
yanliu307
Identifier Type: -
Identifier Source: org_study_id
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