Urologic NeoplasmsNCT04649970
Antegrade Double-J Stent Placement for the Treatment of Malignant Obstructive Uropathy
An observational study of Urologic Neoplasms, run by Université de Sousse.
Trial summary
Ureteral double- J stent is usually inserted by retrograde approach for the treatment of obstructed upper urinary tract. The antegrade approach, can a suitable alternative in certain situations without the need for general or spinal anesthesia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urologic Neoplasms
- What is being tested?
- Antegrade double-J stent
- Type of treatment
- Surgery or procedure
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 2 Feb 2020
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: A total of 174 patients (sexe ratio = 0.51, age range 9-91 years; mean age, 54 years) were included in the study.
Who may be able to join
- malignant uropathy obstruction
Who cannot join
- benign uropathy obstruction
About this study
Official title: Antegrade Double-J Stent Placement for the Treatment of Malignant Obstructive Uropathy: a Single Center Experience
Ureteral double- J stent is usually inserted by retrograde approach for the treatment of obstructed upper urinary tract. The antegrade approach, can a suitable alternative in certain situations without the need for general or spinal anesthesia. The present study demonstrates the indications, success rate, and complications of this approach in the treatment of malignant obstructive uropathy.
Read the detailed description
Data of consecutive patients in whom antegrade ureteral stent¬ing was performed between January 2013 and February 2020 were retrospectively analysed using patient records and radiology reports. A total of 174 patients (sexe ratio = 0.51, age range 9-91 years; mean age, 54 years) were included in the study.
Ureteral obstruction was caused by bladder cancer (n=92), uterin cancer (n=31), prostate cancer (n=28), colorectal cancer (n= 15) and retroperitoneal tumor (n= 8) (Table 1).
- Conditions
- Urologic Neoplasms
- Being tested
- Antegrade double-J stent
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antegrade double-J stentProcedure or surgery
After exchanging the nephrostomy catheter over the J-tipped guidewire, 5 F multipurpose (45° tip) diagnostic vascular catheter was inserted. Once the pelvi¬ureteric junction was crossed and the ureter accessed, a straight hydrophilic guidewire and a catheter were used. Then, the cath-eter was advanced into the bladder over the wire, this guidewire was exchanged for an ultra-stiff guidewire, an 8 or 10 F double J ureteral stent was placed over the guidewire, and the safety kit of the stent was removed. A final fluoroscopic image was stored for correcting the stent position.
| Study group | Role | What they receive |
|---|---|---|
| malignant uropathy | Antegrade double-J stent Receives: Procedure: Antegrade double-J stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patient having Antegrade double-J stent placement for the treatment of malignant obstructive uropathy
double j stent placement succeed or failed
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Jan 2013
- Primary completion29 Jun 2017
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urologic NeoplasmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ammar houssem, Université de Sousse
- Investigators
- ghaassen tlili, PROFESSOR, Study director, university of sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649970
- Sponsor's protocol ID
- U23459
- Status last verified
- Dec 2020
- First submitted
- 24 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tlili G, Ammar H, Dziri S, Ben Ahmed K, Farhat W, Arem S, Acacha E, Gupta R, Rguez A, Jaidane M. Antegrade double-J stent placement for the treatment of malignant obstructive uropathy: A retrospective cohort study. Ann Med Surg (Lond). 2021 Aug 16;69:102726. doi: 10.1016/j.amsu.2021.102726. eCollection 2021 Sep.
PubMed 34466220
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antegrade Double-J Stent Placement for the Treatment of Malignant Obstructive Uropathy: a Single Center Experience
- ClinicalTrials.gov ID
- NCT04649970
- Acronym / sponsor ID
- U23459
- Conditions
- Urologic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Université de SousseUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 2 Dec 2020 (actual)
- 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.
Ureteral double- J stent is usually inserted by retrograde approach for the treatment of obstructed upper urinary tract. The antegrade approach, can a suitable alternative in certain situations without the need for general or spinal anesthesia. The present study demonstrates the indications, success rate, and complications of this approach in the treatment of malignant obstructive uropathy.
Detailed description
Data of consecutive patients in whom antegrade ureteral stent¬ing was performed between January 2013 and February 2020 were retrospectively analysed using patient records and radiology reports. A total of 174 patients (sexe ratio = 0.51, age range 9-91 years; mean age, 54 years) were included in the study.
Ureteral obstruction was caused by bladder cancer (n=92), uterin cancer (n=31), prostate cancer (n=28), colorectal cancer (n= 15) and retroperitoneal tumor (n= 8) (Table 1).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| malignant uropathy | – | Procedure: Antegrade double-J stentAntegrade double-J stent |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 174 patients (sexe ratio = 0.51, age range 9-91 years; mean age, 54 years) were included in the study.
Key inclusion criteria (1 listed)
- malignant uropathy obstruction
Key exclusion criteria (1 listed)
- benign uropathy obstruction
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 |
|---|---|---|
| Antegrade double-J stentAfter exchanging the nephrostomy catheter over the J-tipped guidewire, 5 F multipurpose (45° tip) diagnostic vascular catheter was inserted. Once the pelvi¬ureteric junction was crossed and the ureter accessed, a straight hydrophilic guidewire and a catheter were used. Then, the cath-eter was advanced into the bladder over the wire, this guidewire was exchanged for an ultra-stiff guidewire, an 8 or 10 F double J ureteral stent was placed over the guidewire, and the safety kit of the stent was removed. A final fluoroscopic image was stored for correcting the stent position. | Procedure or surgery | malignant uropathy |
Primary outcome
number of patient having Antegrade double-J stent placement for the treatment of malignant obstructive uropathy
Time frame: 7 years
double j stent placement succeed or failed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Derived from this study: PubMed 34466220Tlili G, Ammar H, Dziri S, Ben Ahmed K, Farhat W, Arem S, Acacha E, Gupta R, Rguez A, Jaidane M. Antegrade double-J stent placement for the treatment of malignant obstructive uropathy: A retrospective cohort study. Ann Med Surg (Lond). 2021 Aug 16;69:102726. doi: 10.1016/j.amsu.2021.102726. eCollection 2021 Sep.
- Individual participant dataSharing planned: Undecided
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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.
ghaassen tlili, PROFESSOR study director
university of sousse
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Neoplasms, run by Université de Sousse.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of patient having Antegrade double-J stent placement for the treatment of malignant obstructive uropathy (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04649970, which also lists 1 linked publication.
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 Dec 2020.