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

NCT01711996 | Withdrawn

• 1 other identifier: 4-2012-0421
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteropelvic Junction Obstruction

Keywords

hydronephrosis; biopsy; biomarker

Outcome Measures

Primary Outcomes (1)

• The level of urinary NGAL and the degree of renal injury

  Analysis of correlation between the level of urinary NGAL and the degree of renal injury

  6 month after operation

Study Arms (3)

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

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• \<Group 1\>
• year old patients with SFU grade 2 or more hydronephrosis without ureteral dilatation
• 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\>
• \. 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\>
• \. 0-3 year old children without any abnormality of urinary tract

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral; Hydronephrosis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 23, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2013
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

KR (1)