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

Phase 2

• Conditions: Malignant Ureteral Obstruction
• Interventions: Device: Silicone-covered metallic stent; Device: Double-J stent

• Registration Number: NCT01823575
• Lead Sponsor: Asan Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-03
• Study Start: 2013-03
• Study First Submitted: 2013-03-29
• Study First Submitted QC: 2013-04-02
• Last Update Submitted: 2013-04-02
• Study First Posted: 2013-04-04
• Last Update Posted: 2013-04-04
• Primary Completion: 2014-08
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Age 20-80 years
2. Malignant mid- to distal ureteral obstruction by abdominal or pelvic malignancy with overt hydronephrosis documented on CT scans
3. Expected life expectancy more than three months

Exclusion Criteria

1. History of unilateral nephrectomy or bladder reconstruction
2. History of kidney transplantation
3. History of severe allergy to contrast media
4. State of dialysis
5. Performance status - 3 or 4 on ECOG scale

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silicone-covered metallic ureteral stent	Silicone-covered metallic stent	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)
Double-J stent	Double-J stent	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.

Primary Outcome Measures

Name	Time	Method
primary patency rate at 3-month F.U.	3 month after stent deployment	Confirmation of patency of the stents with USG and renal biochemistry, without additional intervention.

Secondary Outcome Measures

Name	Time	Method
Primary patency rate at 6- and 12-month F.U.	at 6 and 12 months after stent deployment	Confirmation of patency of the stents with USG and renal biochemistry, without additional intervention.; Assessment of complications in two study groups.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of