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| ID | Type | Description | Link |
|---|---|---|---|
| 307xhk | Other Grant/Funding Number | National Natural Science Foundation of China |
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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| Changhai Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radioactive stent | Experimental | 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. |
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| plastic stent | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radioactive stent | Device | radioactive stent carrying seed iodine 125 |
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| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response rate | The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | In order to research the progression-free survival, the investigators will check the presence of progression disease for each patients until the date of disease progression or death. | 6 months |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Liu, MD,PhD | Contact | 86-13911798288 | 13911798288@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Liu, Doctor | 307 hospital of PLA, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 307 hospital of PLA | Recruiting | Beijing | Beijing Municipality | 10086 | China |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| plastic stent | Device | common plastic stent without carrying seed iodine 125 |
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Overall survival was calculated from the date of randomization until the date of death.
| follow-up in interval of stent insertion and death (1 years) |
| Adverse events | Individual adverse events | 1 year |
| D009369 | Neoplasms |