Overview

This trial is active, not recruiting.

Condition malignant ureteral obstruction
Treatments silicone-covered metallic stent, double-j stent
Phase phase 2
Sponsor Asan Medical Center
Start date March 2013
End date August 2014
Trial size 78 participants
Trial identifier NCT01823575, JHS_URST

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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)
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
(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.
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

Primary Outcomes

Measure
primary patency rate at 3-month F.U.
time frame: 3 month after stent deployment

Secondary Outcomes

Measure
Primary patency rate at 6- and 12-month F.U.
time frame: at 6 and 12 months after stent deployment

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Asan Medical Center.