Antegrade Double-J Stent Placement for the Treatment of Malignant Obstructive Uropathy

• Sponsor: Université de Sousse (Other)
• Overall Status: Completed
• CT.gov ID: NCT04649970
• Collaborator: (none)
• Enrollment: 174
• Actual Duration (Months): 85

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urologic Neoplasms	Procedure: Antegrade double-J stent

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

• Study Type: Observational
• Actual Enrollment: 174 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Antegrade Double-J Stent Placement for the Treatment of Malignant Obstructive Uropathy: a Single Center Experience
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Jun 29, 2017
• Actual Study Completion Date: Feb 2, 2020

Arms and Interventions

Arm

Intervention/Treatment

malignant uropathy Antegrade double-J stent

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.

Outcome Measures

Primary Outcome Measures

1. number of patient having Antegrade double-J stent placement for the treatment of malignant obstructive uropathy [7 years]

   double j stent placement succeed or failed

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• malignant uropathy obstruction

Exclusion Criteria:

• benign uropathy obstruction

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Université de Sousse

Investigators

• Study Director: ghaassen tlili, PROFESSOR, university of sousse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ammar houssem, clinical professor, Université de Sousse
• ClinicalTrials.gov Identifier: NCT04649970
• Other Study ID Numbers: U23459
• First Posted: Dec 2, 2020
• Last Update Posted: Dec 4, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urologic Neoplasms

Study Results

No Results Posted as of Dec 4, 2020