NCT04649970

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2017

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

4.5 years

First QC Date

November 24, 2020

Last Update Submit

December 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

malignant uropathy

Antegrade double-J stent

Procedure: Antegrade double-J stent

Interventions

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.

malignant uropathy

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • malignant uropathy obstruction

You may not qualify if:

  • benign uropathy obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic Diseases

Study Officials

  • ghaassen tlili, PROFESSOR

    university of sousse

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 2, 2020

Study Start

January 1, 2013

Primary Completion

June 29, 2017

Study Completion

February 2, 2020

Last Updated

December 4, 2020

Record last verified: 2020-12