NCT01823575

Comparison of Silicone-covered Metallic Ureteral Stent and Double-J Stent for Malignant Ureteral Obstruction

Comparison of the Efficacy of Silicone-covered Metallic Ureteral Stent and Double-J Stent for Malignant Ureteral Obstruction: A Prospective Randomized Controlled Trial Based on Exploratory Research

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Malignant Ureteral Obstruction

Interventions

Type	Name	Description
DEVICE	Silicone-covered metallic stent	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
DEVICE	Double-J stent	Placement of double-J stent as a conventional treatment to be compared with a new experimental treatment - deployment of silicone-covered metallic stent

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2013-04-04
• Last updated: 2013-04-04

Locations

1 site across 1 country: South Korea