| CTRI Number |
CTRI/2026/03/106457 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prospective longitudinal observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of urinary biomarkers MMP 7 and TIMP 2 before and after surgery in children with pelviureteric junction obstruction. |
|
Scientific Title of Study
|
A Prospective Study Comparing Urinary Biomarkers MMP-7 and TIMP-2 in Children with Pelvic Ureteric Junction Obstruction Before and After Pyeloplasty |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vutukuru lakshmi Sravanthi |
| Designation |
Assistant Professor |
| Affiliation |
AlIMS,Mangalagiri |
| Address |
Room no 329, 3rd floor OPD, Department of Pediatric SUrgery,AIIMS,Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
08885296197 |
| Fax |
|
| Email |
vutukuru.sravanthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vutukuru lakshmi Sravanthi |
| Designation |
Assistant Professor |
| Affiliation |
AlIMS,Mangalagiri |
| Address |
Room no 329, 3rd floor OPD, Department of Pediatric SUrgery,AIIMS,Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
08885296197 |
| Fax |
|
| Email |
vutukuru.sravanthi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vutukuru lakshmi Sravanthi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS,mangalagiri |
| Address |
Room no 329, 3rd floor OPD, Department of Pediatric SUrgery,AIIMS,Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7717602868 |
| Fax |
|
| Email |
vutukuru.sravanthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Mangalagiri, Guntur,Andhra pradesh, India, pin: 522503 (intramural grant - IMF:2025-02) |
|
|
Primary Sponsor
|
| Name |
AIIMS Mangalagiri intramural grant |
| Address |
All India Institute of Medical Sciences,Mangalagiri,Near NH-16,Guntur,Andhra Pradesh,India 522503 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| sravanthi vutukuru |
AIIMS,Mangalagiri |
room no: 329, OPD, Department of Pediatric Surgery, AIIMS,Mangalagiri
Guntur
ANDHRA PRADESH |
7717902868
vutukuru.sravanthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE,AIIMS,Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q620||Congenital hydronephrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
unilateral PUJO in children with 1m -18yrs |
|
| ExclusionCriteria |
| Details |
Bilateral PUJO, nephrotic syndrome, glomerulonephritis, diabetes mellitus, secondary PUJO due to stone disease, children with associated renal problems in addition to PUJO such as vesicoureteric reflux (VUR), posterior urethral valve (PUV), vesicoureteric junction obstruction (VUJO), and multi-cystic dysplastic kidney (MCDK) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Urinary MMP-7 and TIMP-2 levels will demonstrate significant changes following pyeloplasty, potentially correlating with functional improvement |
1. 12 weeks
2. 24 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pelvic ureteric junction obstruction is an important cause of obstructive uropathy in children and may lead to progressive renal damage if untreated Although pyeloplasty is the standard treatment postoperative assessment of renal recovery mainly relies on imaging methods such as ultrasound and diuretic renography which may not detect early functional improvement Matrix metalloproteinase 7 and tissue inhibitor of metalloproteinases 2 are involved in extracellular matrix remodeling inflammation and renal repair and may serve as urinary biomarkers for monitoring renal recovery This prospective observational study will include 30 children aged 1 month to 18 years with unilateral pelvic ureteric junction obstruction undergoing pyeloplasty at AIIMS Mangalagiri and Government General Hospital VijayawadaUrine samples will be collected at baseline intraoperatively from the renal pelvis and at 3 months and 6 months after surgery and the levels of MMP 7 and TIMP 2 will be measured using ELISA assays ultrasound diuretic renogram and estimated glomerular filtration rate will be used to assess renal functionStatistical analysis will compare biomarker levels before and after surgery and evaluate correlations with functional outcomesThe study is expected to demonstrate significant changes in urinary MMP 7 and TIMP 2 following pyeloplasty reflecting early renal remodeling and recoveryEstablishing these biomarkers may provide a non invasive method for monitoring postoperative renal improvement and may reduce dependence on repeated imaging |