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Malignant biliary obstruction is a common clinical condition caused by various malignancies. Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the most important methods for relieving malignant biliary obstruction. However, the benefit for the survival of the patients with palliation of the stent treatment is limited because no therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by the success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded with 125I radioactive seeds has been developed in our institute. After ex vivo and in vivo evaluations for the delivery system, the investigators prospectively compare the responses to treatment with this radiation biliary stent, versus the conventional biliary SEMS in patient with malignant biliary obstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| novel radiation stent | Active Comparator | Patients undergo placement of a novel biliary stent loaded with 125I seeds on day 1. Intervention: Device: self-expandable 125I radioactive seeds-loaded-stent |
|
| conventional stent | Experimental | Patients undergo placement of a conventional nitinol SEMS on day1. Intervention: Device: self-expandable biliary nitinol alloys stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-expandable 125I radioactive seeds-loaded-stent | Device | Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Mean Survival and Median Survival | follow-up in interval of stent insertion and death (3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | follow-up in interval of stent insertion and death (3 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gao-jun Teng, MD, PhD | Zhong-Da Hospital, Southeast University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital,Southeast University | Nanjing | Jiangsu | 210009 | China |
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|
| self-expandable biliary nitinol alloys stent | Device | Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1. |
|
|
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D010190 | Pancreatic Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
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