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

July 29, 2023 updated by: Yasser A. Noureldin, Benha University

Which is Better: Narrow vs. Wide Focus for Shock Wave Lithotripsy of Renal Stones

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Kalyobiya
      • Banhā, Kalyobiya, Egypt, 13518

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Group 1 will undergo Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks
Procedure: Shock Wave Lithotripsy (SWL)
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
Active Comparator: Group 2
Group 2 will undergo Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks
Procedure: Shock Wave Lithotripsy (SWL)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of efficacy of Shock Wave Lithotripsy (SWL) by calculation of the percentage (%) of stone free
Time Frame: 1 year

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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the degree of renal injury using renal injury markers
Time Frame: 1 year

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.
1 year
Assessment of the presence of peri-renal hematoma
Time Frame: 1 year

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).
1 year
Assessment of the changes in renal cortical thickness
Time Frame: 1 year

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
1 year
Measurement of the changes in the Renal Resistive Index (RRI)
Time Frame: 1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Yasser Noureldin, MD, PhD, Benha University
  • Study Chair: Ahmed Abdelbaky, MD, PhD, Benha University
  • Study Director: Walid Ibrahim, MD, PhD, Benha University
  • Study Director: Ezzat Elnahife, MD, Benha University
  • Study Director: Salah El Hamshary, MD, PhD, Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 29, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD 1-11-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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