The Correlation Between Renal Injury and Biomarkers in Pediatric Ureteropelvic Junction Obstruction Patients

May 3, 2021 updated by: Yonsei University
Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction (UPJO) patients. We are trying to analyze whether it is related with the grade of renal injury in UPJO patients.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine

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

No older than 3 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Group 1: 20 patients with UPJO undergo pyeloplasty Group 2: 20 patients with hydronephrosis who does not meet the indication of pyeloplasty Group 3: 20 normal control

Description

Inclusion Criteria:

<Group 1>

  1. 0-3 year old patients with SFU grade 2 or more hydronephrosis without ureteral dilatation
  2. needs pyeloplasty due to differential renal function (DRF)<40%, decreased DRF by more than 5%, development of urinary tract infection, development of urinary stone, and development of pain related with UPJO <Group 2>

1. 0-3 year old patients with SFU grade 3 or 4 hydronephrosis without ureteral dilatation 2. doesn't meet the above criteria for the indication of pyeloplasty <Group 3>

1. 0-3 year old children without any abnormality of urinary tract

Exclusion Criteria:

<Group 1>

  1. patients with contralateral disease affecting DRF
  2. history of previous urinary tract surgery
  3. follow up loss before diuretic renogram performed at 6-12 months from operation <Group 2, 3>

1. patients with contralateral disease affecting DRF 2. history of previous urinary tract surgery

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

Cohorts and Interventions

Group / Cohort
UPJO
0-3 year old hydronephrosis patients without ureter dilatation who undergo pyeloplasty
Hydronephrosis
0-3 year old hydronephrosis patients without ureter dilatation who does not meet the indication of pyeloplasty
Normal
0-3 year old children without hydronephrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of urinary NGAL and the degree of renal injury
Time Frame: 6 month after operation
Analysis of correlation between the level of urinary NGAL and the degree of renal injury
6 month after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

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

August 1, 2012

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (ESTIMATE)

October 23, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0421

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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