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

Primary Purpose

Malignant Ureteral Obstruction

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Silicone-covered metallic stent
Double-J stent
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Ureteral Obstruction focused on measuring malignant ureteral obstruction, silicone-covered metallic ureteral stent, double-J stent

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Silicone-covered metallic ureteral stent

Double-J stent

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

primary patency rate at 3-month F.U.
Confirmation of patency of the stents with USG and renal biochemistry, without additional intervention.

Secondary Outcome Measures

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.

Full Information

First Posted
March 29, 2013
Last Updated
April 2, 2013
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01823575
Brief Title
Comparison of Silicone-covered Metallic Ureteral Stent and Double-J Stent for Malignant Ureteral Obstruction
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Ureteral Obstruction
Keywords
malignant ureteral obstruction, silicone-covered metallic ureteral stent, double-J stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Silicone-covered metallic ureteral stent
Arm Type
Experimental
Arm Description
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)
Arm Title
Double-J stent
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Silicone-covered metallic stent
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Double-J stent
Intervention Description
Placement of double-J stent as a conventional treatment to be compared with a new experimental treatment - deployment of silicone-covered metallic stent
Primary Outcome Measure Information:
Title
primary patency rate at 3-month F.U.
Description
Confirmation of patency of the stents with USG and renal biochemistry, without additional intervention.
Time Frame
3 month after stent deployment
Secondary Outcome Measure Information:
Title
Primary patency rate at 6- and 12-month F.U.
Description
Confirmation of patency of the stents with USG and renal biochemistry, without additional intervention. Assessment of complications in two study groups.
Time Frame
at 6 and 12 months after stent deployment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Hoon Shin, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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