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

Not Applicable

• Conditions: Percutaneous Nephrolithotomy; Acute Kidney Injury; Renal Calculi; Extracorporeal Shockwave Lithotripsy
• Interventions: Procedure: Extracorporeal Shock Wave Lithotripsy; Procedure: Percutaneous nephrolithotomy

• Registration Number: NCT05077007
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-04
• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-13
• Last Update Submitted: 2022-02-18
• Last Update Posted: 2022-02-22
• Primary Completion: 2022-08-22
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

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Exclusion Criteria

• Exclusion criteria for patients

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extracorporeal Shock Wave Lithotripsy	Extracorporeal Shock Wave Lithotripsy	patients suffering of pelvic renal stones underwent Extracorporeal Shock Wave Lithotripsy
Percutaneous nephrolithotomy	Percutaneous nephrolithotomy	patients suffering of pelvic renal stones underwent Percutaneous nephrolithotomy

Primary Outcome Measures

Name	Time	Method
Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers	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

Trial Locations

Locations (1)

Urology Department, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt