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

Ain Shams University

Status: Unknown

Conditions: Extracorporeal Shockwave Lithotripsy; Percutaneous Nephrolithotomy; Acute Kidney Injury; Renal Calculi

Treatments: Procedure: Percutaneous nephrolithotomy; Procedure: Extracorporeal Shock Wave Lithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05077007

FMASU R 77/ 2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Percutaneous nephrolithotomy

Active Comparator group

Description:

patients suffering of pelvic renal stones underwent Percutaneous nephrolithotomy

Treatment:

Procedure: Percutaneous nephrolithotomy

Extracorporeal Shock Wave Lithotripsy

Active Comparator group

Description:

patients suffering of pelvic renal stones underwent Extracorporeal Shock Wave Lithotripsy

Treatment:

Procedure: Extracorporeal Shock Wave Lithotripsy

control group

No Intervention group

Description:

Healthy volunteers with negative history of renal stones or renal impairment to measure the level of urinary markers in their urine samples