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

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ClinicalTrials.gov Identifier: NCT01711996
Recruitment Status : Unknown
Verified October 2012 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease
Ureteropelvic Junction Obstruction

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2012
Actual Primary Completion Date : August 2012
Estimated Study Completion Date : August 2013

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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711996


Contacts
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Contact: Han Sang Won, MD 82-2-2228-2316, swhan@yuhs.ac

Locations
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Korea, Republic of
Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sang Won MD, MD    82-2-2228-2316    swhan@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01711996     History of Changes
Other Study ID Numbers: 4-2012-0421
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012

Keywords provided by Yonsei University:
hydronephrosis
biopsy
biomarker

Additional relevant MeSH terms:
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Hydronephrosis
Ureteral Obstruction
Multicystic Dysplastic Kidney
Kidney Diseases
Urologic Diseases
Ureteral Diseases
Urogenital Abnormalities
Kidney Diseases, Cystic
Congenital Abnormalities