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Malignant ureteral obstruction often necessitates chronic urinary diversion and is associated with high rates of failure with traditional double-J ureteral stents. To overcome drawbacks of the double-J stent, recently, metallic stents have been used to manage for palliative treatment in patients with ureteral obstruction associated with end stage malignant disease. The success rates of metallic stents have been reported to be high and the method proved to be useful in patients with malignant ureteral obstruction. In addition, covered metallic stents have many advantages compared with bare metallic stents, such as lower rate of tissue invasion and higher patency rate. However, there is little investigation about comparison of clinical efficacy between covered-metallic stents and double-J stents in malignant ureteral obstruction.
Therefore, investigators plan to perform a prospective randomized study to compare clinical efficacy of silicone-covered metallic ureteral stent and double-J ureteral stent in patients with malignant ureteral obstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silicone-covered metallic ureteral stent | Experimental | Deployment of a silicone-covered metallic ureteral stent for malignant ureteral obstruction and compare the results with placement of a double-J stent in terms of primary patency rate at 3 month follow-up (primary end point) |
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| Double-J stent | Active Comparator | Placement of a double-J stent for malignant ureteral obstruction and compare these results to deployment of a silicone-covered metallic stent in terms of primary patency rate at 3 month follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicone-covered metallic stent | Device | deployment of silicone-covered metallic stent for malignant ureteral obstruction as a new therapy as compared with placement of double-J stent as a conventional therapy |
| Measure | Description | Time Frame |
|---|---|---|
| primary patency rate at 3-month F.U. | Confirmation of patency of the stents with USG and renal biochemistry, without additional intervention. | 3 month after stent deployment |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency rate at 6- and 12-month F.U. | Confirmation of patency of the stents with USG and renal biochemistry, without additional intervention. Assessment of complications in two study groups. | at 6 and 12 months after stent deployment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji Hoon Shin, M.D. | Asan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
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| Double-J stent | Device | Placement of double-J stent as a conventional treatment to be compared with a new experimental treatment - deployment of silicone-covered metallic stent |
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