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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01823575

Enrollment

Registered

2013-04-04

Start date

2013-03-31

Completion date

2014-09-30

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Ureteral Obstruction

Keywords

malignant ureteral obstruction, silicone-covered metallic ureteral stent, double-J stent

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.

Interventions

DEVICESilicone-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

DEVICEDouble-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026