Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers

Overview

The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 22, 2021

Detailed Description

The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures and assess their usefulness as diagnostic biomarkers for AKI and the relationship between the selected RNA based biomarker panel and clinicopathological changes of patients.

Interventions

  • Procedure: Percutaneous nephrolithotomy
    • Endoscopic stone Extraction from the kidney by making a puncture and dilate a tract direct into the kidney through muscle wall and renal parenchyma
  • Procedure: Extracorporeal Shock Wave Lithotripsy
    • Using Shock waves from outside the body targeted at a kidney stone causing the stone to fragment. The stones are broken into tiny pieces.

Arms, Groups and Cohorts

  • Active Comparator: Percutaneous nephrolithotomy
    • patients suffering of pelvic renal stones underwent Percutaneous nephrolithotomy
  • Active Comparator: Extracorporeal Shock Wave Lithotripsy
    • patients suffering of pelvic renal stones underwent Extracorporeal Shock Wave Lithotripsy
  • No Intervention: control group
    • Healthy volunteers with negative history of renal stones or renal impairment to measure the level of urinary markers in their urine samples

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers
    • Time Frame: Before the procedure by 2hours and after the procedure by 2 and 24 hours
    • Evaluation of kidney injury after procedures PCNL and ESWL by measuring the change of the level of novel non-coding lnc-RNA profile in urine

Participating in This Clinical Trial

Inclusion Criteria

Inclusion criteria for patients : 1. Patients undergoing treatment for a stone(s) located in the kidney less than 2 cm 2. Radiopaque stone 3. Able and willing to give informed consent Inclusion criteria for Healthy volunteers 1. No history of kidney or stone disease 2. Asymptomatic 3. No indwelling ureteral stent 4. Willing to provide medical history information 5. Able and willing to give informed consent Exclusion Criteria:

Exclusion criteria for patients 1. Active urinary tract infection 2. Bleeding disorder 3. Chronic renal failure (eGFR<30) 4. Ureteral stone

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Collaborator
    • Science,Technology & Innovation Funding Authority
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • waleed Mousa, Principal Investigator, Urology Department, Ain Shams University, Abassia, Cairo
  • Overall Contact(s)
    • waleed Mousa, MD, +201067628771, waleedmousa2@yahoo.com

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