Clinical trial NCT04759599: 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
Overall status: RECRUITING
Phase: NA
Conditions: Renal Stone
Treatment Side Effects
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of efficacy of Shock Wave Lithotripsy (SWL) by calculation of the percentage (%) of stone free
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of the degree of renal injury using renal injury markers
timeFrame: 1 year
measure: Assessment of the presence of peri-renal hematoma
timeFrame: 1 year
measure: Assessment of the changes in renal cortical thickness
timeFrame: 1 year
measure: Measurement of the changes in the Renal Resistive Index (RRI)
timeFrame: 1 year
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Faculty of Medicine, Benha University
state: Kalyobiya
Study officials:
affiliation: Benha University
name: Yasser Noureldin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University
name: Ahmed Abdelbaky, MD, PhD
role: STUDY_CHAIR
affiliation: Benha University
name: Walid Ibrahim, MD, PhD
role: STUDY_DIRECTOR
affiliation: Benha University
name: Ezzat Elnahife, MD
role: STUDY_DIRECTOR
affiliation: Benha University
name: Salah El Hamshary, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.