Malignant Ureteral ObstructionPhase 2NCT01823575
Comparison of Silicone-covered Metallic Ureteral Stent and Double-J Stent for Malignant Ureteral Obstruction
A Phase 2 study testing Silicone-covered metallic stent and Double-J stent in people with Malignant Ureteral Obstruction, run by Asan Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Malignant Ureteral Obstruction
- What is being tested?
- Silicone-covered metallic stent and Double-J stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Malignant Ureteral Obstruction
- Being tested
- Silicone-covered metallic stent, Double-J stent
- Keywords
- malignant ureteral obstruction, silicone-covered metallic ureteral stent, double-J stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone-covered metallic stentDevice
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 stentDevice
Placement of double-J stent as a conventional treatment to be compared with a new experimental treatment - deployment of silicone-covered metallic stent
| Study group | Role | What they receive |
|---|---|---|
| Silicone-covered metallic ureteral stent | 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) Receives: Device: Silicone-covered metallic stent |
| Double-J stent | 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. Receives: Device: Double-J stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary patency rate at 3-month F.U.
Confirmation of patency of the stents with USG and renal biochemistry, without additional intervention.
Measured: 3 month after stent deployment
Secondary outcomes (1)
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.
Measured: at 6 and 12 months after stent deployment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Ureteral ObstructionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hoon Shin, Asan Medical Center
- Investigators
- Ji Hoon Shin, M.D., Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823575
- Sponsor's protocol ID
- JHS_URST
- Status last verified
- Mar 2013
- First submitted
- 29 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01823575
- Acronym / sponsor ID
- JHS_URST
- Conditions
- Malignant Ureteral Obstruction
- Keywords
- malignant ureteral obstruction, silicone-covered metallic ureteral stent, double-J stent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silicone-covered metallic ureteral stent | Experimental | Device: Silicone-covered metallic stentDeployment 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) |
| Double-J stent | Active comparator | Device: Double-J stentPlacement 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silicone-covered metallic stentdeployment 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 | Device | Silicone-covered metallic ureteral stent |
| Double-J stentPlacement of double-J stent as a conventional treatment to be compared with a new experimental treatment - deployment of silicone-covered metallic stent | Device | Double-J stent |
Primary outcome
primary patency rate at 3-month F.U.
Time frame: 3 month after stent deployment
Confirmation of patency of the stents with USG and renal biochemistry, without additional intervention.
1 secondary outcome
Primary patency rate at 6- and 12-month F.U.
Time frame: at 6 and 12 months after stent deployment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
Related trials for Malignant Ureteral Obstruction
Not yet recruiting
Safety and Efficacy of Ultrasound-Guided Percutaneous Nephrostomy in Oncology Patients
Obstructive Uropathy, Hydronephrosis
Recruiting
Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction
Hydronephrosis; Obstruction, Ureter, Renal Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Hoon Shin, M.D. study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Silicone-covered metallic stent and Double-J stent in people with Malignant Ureteral Obstruction, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary patency rate at 3-month F.U. (time frame: 3 month after stent deployment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.