Radiation Stent Versus Self-expanding Metallic Stents (SEMS) for Palliative Treatment of Malignant Biliary Stricture
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|ClinicalTrials.gov Identifier: NCT01320241|
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : April 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocellular Carcinoma Pancreatic Cancer Gallbladder Cancer Metastatic Carcinoma||Device: self-expandable 125I radioactive seeds-loaded-stent Device: self-expandable biliary nitinol alloys stent||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Unicentric RCT About Novel Radiation Stent Versus Nitinol SEMS for Palliative Treatment of Malignant Biliary Stricture|
|Study Start Date :||November 2008|
|Primary Completion Date :||March 2012|
|Study Completion Date :||March 2012|
Active Comparator: novel radiation stent
Patients undergo placement of a novel biliary stent loaded with 125I seeds on day 1.
Intervention: Device: self-expandable 125I radioactive seeds-loaded-stent
Device: self-expandable 125I radioactive seeds-loaded-stent
Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.
Other Name: irradiation biliary stent
Experimental: conventional stent
Patients undergo placement of a conventional nitinol SEMS on day1.
Intervention: Device: self-expandable biliary nitinol alloys stent
Device: self-expandable biliary nitinol alloys stent
Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.
Other Name: conventional SEMS
- Overall Mean Survival and Median Survival [ Time Frame: follow-up in interval of stent insertion and death (3 years) ]
- Number of Participants with Adverse Events as a Measure of Technical Success, Clinical Success, Safety (including WBC and Immunological changes of lab, Leakage of the radioactive seeds and Complications related to the procedure. [ Time Frame: follow-up in interval of stent insertion and death (3 years) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320241
|Zhongda Hospital,Southeast University|
|Nanjing, Jiangsu, China, 210009|
|Principal Investigator:||Gao-jun Teng, MD, PhD||Zhong-Da Hospital, Southeast University|