Antegrade Double-J Stent Placement for the Treatment of Malignant Obstructive Uropathy
December 2, 2020 updated by: ammar houssem, Université de Sousse
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
174
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- malignant uropathy obstruction
Exclusion Criteria:
- benign uropathy obstruction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
malignant uropathy
Antegrade double-J stent
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
7 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ghaassen tlili, PROFESSOR, university of sousse
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
June 29, 2017
Study Completion (Actual)
February 2, 2020
Study Registration Dates
First Submitted
November 24, 2020
First Submitted That Met QC Criteria
November 24, 2020
First Posted (Actual)
December 2, 2020
Study Record Updates
Last Update Posted (Actual)
December 4, 2020
Last Update Submitted That Met QC Criteria
December 2, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U23459
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.