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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Malignant Ureteral Obstruction

Intervention / Treatment
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* Device: Silicone-covered metallic stent
* Device: Double-J stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-80 years Malignant mid- to distal ureteral obstruction by abdominal or pelvic malignancy with overt hydronephrosis documented on CT scans Expected life expectancy more than three months Exclusion Criteria: History of unilateral nephrectomy or bladder reconstruction History of kidney transplantation History of severe allergy to contrast media State of dialysis Performance status - 3 or 4 on ECOG scale

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silicone-covered metallic ureteral stent<br>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) | Device: Silicone-covered metallic stent<br>* 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<br>|
| Active Comparator: Double-J stent<br>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. | Device: Double-J stent<br>* Placement of double-J stent as a conventional treatment to be compared with a new experimental treatment - deployment of silicone-covered metallic stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant ureteral obstruction, silicone-covered metallic ureteral stent, double-J stent