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

Malignant Ureteral Obstruction Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01823575
• Other study ID #: JHS_URST
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 29, 2013
• Last updated: April 2, 2013
• Start date: March 2013
• Est. completion date: September 2014

Study information

• Verified date: March 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Ureteral Obstruction
• Ureteral Obstruction

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes