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

NCT ID: NCT05077007

Last Updated: 2022-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-11-01

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury Renal Calculi Percutaneous Nephrolithotomy Extracorporeal Shockwave Lithotripsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Percutaneous nephrolithotomy

patients suffering of pelvic renal stones underwent Percutaneous nephrolithotomy

Group Type ACTIVE_COMPARATOR

Percutaneous nephrolithotomy

Intervention Type PROCEDURE

Endoscopic stone Extraction from the kidney by making a puncture and dilate a tract direct into the kidney through muscle wall and renal parenchyma

Extracorporeal Shock Wave Lithotripsy

patients suffering of pelvic renal stones underwent Extracorporeal Shock Wave Lithotripsy

Group Type ACTIVE_COMPARATOR

Extracorporeal Shock Wave Lithotripsy

Intervention Type PROCEDURE

Using Shock waves from outside the body targeted at a kidney stone causing the stone to fragment. The stones are broken into tiny pieces.

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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PCNL ESWL

Eligibility Criteria

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Inclusion Criteria

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


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

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Science,Technology & Innovation Funding Authority

UNKNOWN

Sponsor Role collaborator

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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waleed Mousa

Role: PRINCIPAL_INVESTIGATOR

Urology Department, Ain Shams University, Abassia, Cairo

Locations

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Urology Department, Faculty of Medicine, Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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waleed Mousa, MD

Role: CONTACT

+201067628771

Ahmed Tawfick, MD

Role: CONTACT

+201223112243

Facility Contacts

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waleed Mousa, MD

Role: primary

01067628771

Other Identifiers

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FMASU R 77/ 2021

Identifier Type: -

Identifier Source: org_study_id

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