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Efficacy and Safety of Narrow Focus (F1) Versus Wide Focus (F3) of Shock Wave Lithotripsy (SWL) for Renal Calculi

Primary Purpose

Renal Stone, Treatment Side Effects

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Shock Wave Lithotripsy (SWL)
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Adult patients (>18years old) with 1-2 cm single renal stone.
  2. Normal functioning kidney.

Exclusion Criteria:

  1. Pregnancy.
  2. Bleeding diatheses.
  3. Radiolucent stones.
  4. Radio-opaque stones with Hounsfield Unit (HU) > 1200
  5. Patients with a pacemaker.
  6. Active Urinary Tract Infection (UTI).
  7. Severe skeletal malformations.
  8. Morbid obesity with Body Mass Index (BMI) ≥40 kg/m2.
  9. Renal artery aneurysm at the same site of the stone.
  10. Anatomical obstruction distal to the stone.
  11. Patients with renal impairment with serum creatinine > 1.2 mg/dL.

Sites / Locations

  • Faculty of Medicine, Benha UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Group 1 will undergo Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks

Group 2 will undergo Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks

Outcomes

Primary Outcome Measures

Assessment of efficacy of Shock Wave Lithotripsy (SWL) by calculation of the percentage (%) of stone free
Assessment of efficacy of Shock Wave Lithotripsy (SWL) and its success by calculation of stone free (%) following each session with a maximum of 3 Shock Wave Lithotripsy (SWL) sessions, 2 weeks a part, using pelvi-abdominal Ultrasound (US) and Kidney-Ureter-Bladder (KUB) and the presence of significant residual stone >4 mm will be considered "non-stone free" and the final stone free status (%) will be calculated at one month following the last session of Shock Wave Lithotripsy (SWL). Shock Wave Lithotripsy (SWL) failure will be defined as failure to reach stone free status (%) one month after 3rd session.

Secondary Outcome Measures

Assessment of the degree of renal injury using renal injury markers
Assessment of the degree of renal injury using renal injury markers as follow: - Urine analysis for neutrophil gelatinase-associated lipocalin (NGAL) (ng/dL) & Kidney Injury Molecule 1 (KIM-1) (ng/dL) will be measured measured with enzyme-linked immunosorbent assay (ELISA) method before, 2 hours after and 72 hours after the 1st Shock Wave Lithotripsy (SWL) session.
Assessment of the presence of peri-renal hematoma
Assessment of the presence of peri-renal hematoma will be conducted as follow: - Ultrasonography (US) will be done 24 hours after Shock Wave Lithotripsy (SWL) session to search for the presence of peri-renal hematoma and measure its size (cc).
Assessment of the changes in renal cortical thickness
Changes in the renal cortical thickness will be assessed as follow: - Ultrasonography (US) will be done before and after 6 months post Shock Wave Lithotripsy (SWL) for assessment of renal cortical thickness (mm) and the pre- and post-SWL measurements will be compared
Measurement of the changes in the Renal Resistive Index (RRI)
Renal Resistive Index (RRI) will be measured in the arcuate arteries using the following formula "RRI can be calculated as (peak systolic velocity - end diastolic velocity)/peak systolic velocity" before and 24 hours after Shock Wave Lithotripsy (SWL) using Doppler Ultrasound and changes will be recorded

Full Information

First Posted
February 3, 2021
Last Updated
July 29, 2023
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT04759599
Brief Title
Efficacy and Safety of Narrow Focus (F1) Versus Wide Focus (F3) of Shock Wave Lithotripsy (SWL) for Renal Calculi
Official Title
Which is Better: Narrow vs. Wide Focus for Shock Wave Lithotripsy of Renal Stones
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to compare the narrow focus (F1) versus the wide focus (F3) in terms of the efficacy of Shock Wave Lithotripsy (SWL) in the management of renal calculi 1-2 cm and their injurious effect on the kidney.
Detailed Description
Recently, some Shock Wave Lithotripsy (SWL) devices have been announced in the market with a different focus points. One early experimental study found that stone disintegration is better with small focusing points than larger focusing points. Nevertheless, these findings, in terms of the efficacy of stone disintegration, need to be validated in-vivo. Furthermore, the effect of focal size on renal injury during SWL need to be studied as well. Therefore, the objectives of this study are to compare the effect of using the narrow focus of 2mm (F1) versus the wide focus of 8 mm (F3) on the Stone Free Rate (SFR) following SWL for renal stones 1-2cm and estimating renal injury effect of F1 vs. F3 by urinary renal injury markers such as neutrophil gelatinase-associated lipocalin (NGAL) for assessment of proximal and distal renal tubules injury & Kidney Injury Molecule-1 (KIM-1) for assessment of proximal renal tubules injury). The SWL device: Lithotripter type: Piezo Lith3000 plus ( from Richard Wolf, Germany.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone, Treatment Side Effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Group 1 will undergo Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Group 2 will undergo Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks
Intervention Type
Procedure
Intervention Name(s)
Shock Wave Lithotripsy (SWL)
Intervention Description
Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks or Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks
Primary Outcome Measure Information:
Title
Assessment of efficacy of Shock Wave Lithotripsy (SWL) by calculation of the percentage (%) of stone free
Description
Assessment of efficacy of Shock Wave Lithotripsy (SWL) and its success by calculation of stone free (%) following each session with a maximum of 3 Shock Wave Lithotripsy (SWL) sessions, 2 weeks a part, using pelvi-abdominal Ultrasound (US) and Kidney-Ureter-Bladder (KUB) and the presence of significant residual stone >4 mm will be considered "non-stone free" and the final stone free status (%) will be calculated at one month following the last session of Shock Wave Lithotripsy (SWL). Shock Wave Lithotripsy (SWL) failure will be defined as failure to reach stone free status (%) one month after 3rd session.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Assessment of the degree of renal injury using renal injury markers
Description
Assessment of the degree of renal injury using renal injury markers as follow: - Urine analysis for neutrophil gelatinase-associated lipocalin (NGAL) (ng/dL) & Kidney Injury Molecule 1 (KIM-1) (ng/dL) will be measured measured with enzyme-linked immunosorbent assay (ELISA) method before, 2 hours after and 72 hours after the 1st Shock Wave Lithotripsy (SWL) session.
Time Frame
1 year
Title
Assessment of the presence of peri-renal hematoma
Description
Assessment of the presence of peri-renal hematoma will be conducted as follow: - Ultrasonography (US) will be done 24 hours after Shock Wave Lithotripsy (SWL) session to search for the presence of peri-renal hematoma and measure its size (cc).
Time Frame
1 year
Title
Assessment of the changes in renal cortical thickness
Description
Changes in the renal cortical thickness will be assessed as follow: - Ultrasonography (US) will be done before and after 6 months post Shock Wave Lithotripsy (SWL) for assessment of renal cortical thickness (mm) and the pre- and post-SWL measurements will be compared
Time Frame
1 year
Title
Measurement of the changes in the Renal Resistive Index (RRI)
Description
Renal Resistive Index (RRI) will be measured in the arcuate arteries using the following formula "RRI can be calculated as (peak systolic velocity - end diastolic velocity)/peak systolic velocity" before and 24 hours after Shock Wave Lithotripsy (SWL) using Doppler Ultrasound and changes will be recorded
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients (>18years old) with 1-2 cm single renal stone. Normal functioning kidney. Exclusion Criteria: Pregnancy. Bleeding diatheses. Radiolucent stones. Radio-opaque stones with Hounsfield Unit (HU) > 1200 Patients with a pacemaker. Active Urinary Tract Infection (UTI). Severe skeletal malformations. Morbid obesity with Body Mass Index (BMI) ≥40 kg/m2. Renal artery aneurysm at the same site of the stone. Anatomical obstruction distal to the stone. Patients with renal impairment with serum creatinine > 1.2 mg/dL.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasser Noureldin, MD, PhD
Phone
01225352115
Email
dryasser.noor@fmed.bu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ezzat Elnahife, MD
Phone
01008117250
Email
ezatsaid14@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser Noureldin, MD, PhD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelbaky, MD, PhD
Organizational Affiliation
Benha University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Walid Ibrahim, MD, PhD
Organizational Affiliation
Benha University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ezzat Elnahife, MD
Organizational Affiliation
Benha University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Salah El Hamshary, MD, PhD
Organizational Affiliation
Benha University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Benha University
City
Banhā
State/Province
Kalyobiya
ZIP/Postal Code
13518
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasser Noureldin, MD, PhD
Phone
01225352115
Email
dryasser.noor@fmed.bu.edu.eg
First Name & Middle Initial & Last Name & Degree
Ezzat Elnahife, MD
Phone
01008117250
Email
ezatsaid14@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
21883851
Citation
Turney BW, Reynard JM, Noble JG, Keoghane SR. Trends in urological stone disease. BJU Int. 2012 Apr;109(7):1082-7. doi: 10.1111/j.1464-410X.2011.10495.x. Epub 2011 Aug 26.
Results Reference
background
PubMed Identifier
18680494
Citation
Connors BA, Evan AP, Blomgren PM, Handa RK, Willis LR, Gao S. Effect of initial shock wave voltage on shock wave lithotripsy-induced lesion size during step-wise voltage ramping. BJU Int. 2009 Jan;103(1):104-7. doi: 10.1111/j.1464-410X.2008.07922.x. Epub 2008 Aug 1.
Results Reference
background
PubMed Identifier
21252674
Citation
Devarajan P. Biomarkers for the early detection of acute kidney injury. Curr Opin Pediatr. 2011 Apr;23(2):194-200. doi: 10.1097/MOP.0b013e328343f4dd.
Results Reference
background
PubMed Identifier
31925550
Citation
Veser J, Jahrreiss V, Seitz C, Ozsoy M. The effect of focus size and intensity on stone fragmentation in SWL on a piezoelectric lithotripter. World J Urol. 2020 Oct;38(10):2645-2650. doi: 10.1007/s00345-019-03069-y. Epub 2020 Jan 10.
Results Reference
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Efficacy and Safety of Narrow Focus (F1) Versus Wide Focus (F3) of Shock Wave Lithotripsy (SWL) for Renal Calculi

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