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.

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

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.

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