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

• Sponsor: Benha University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04759599
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.9
• Patients Per Site Per Month: 7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Stone; Treatment Side Effects	Procedure: Shock Wave Lithotripsy (SWL)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Which is Better: Narrow vs. Wide Focus for Shock Wave Lithotripsy of Renal Stones
• Actual Study Start Date: Feb 1, 2021
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Assessment of efficacy of Shock Wave Lithotripsy (SWL) by calculation of the percentage (%) of stone free [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.

Secondary Outcome Measures

1. Assessment of the degree of renal injury using renal injury markers [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.

2. Assessment of the presence of peri-renal hematoma [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).

3. Assessment of the changes in renal cortical thickness [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

4. Measurement of the changes in the Renal Resistive Index (RRI) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Benha University	Banhā	Kalyobiya	Egypt	13518

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.
• 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.
• Veser J, Jahrreiss V, Seitz C, Özsoy 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.

• Responsible Party: Yasser A. Noureldin, Assistant Professor of Urology, Benha University
• ClinicalTrials.gov Identifier: NCT04759599
• Other Study ID Numbers: MD 1-11-2020
• First Posted: Feb 18, 2021
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis

Study Results

No Results Posted as of Jul 28, 2022