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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04649970
Other study ID # U23459
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2013
Est. completion date February 2, 2020

Study information

Verified date December 2020
Source Université de Sousse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The present study demonstrates the indications, success rate, and complications of this approach in the treatment of malignant obstructive uropathy.


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).


Recruitment information / eligibility

Status Completed
Enrollment 174
Est. completion date February 2, 2020
Est. primary completion date June 29, 2017
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - malignant uropathy obstruction Exclusion Criteria: - benign uropathy obstruction

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Université de Sousse

Outcome

Type Measure Description Time frame Safety issue
Primary number of patient having Antegrade double-J stent placement for the treatment of malignant obstructive uropathy double j stent placement succeed or failed 7 years
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