Narrow Versus Wide Focal Zones for Shock Wave Lithotripsy of Renal Calculi

This study is currently recruiting participants.
Verified February 2014 by St. Michael's Hospital, Toronto
Sponsor:
Collaborators:
University of Toronto
University of Western Ontario, Canada
University of British Columbia
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01226875
First received: October 20, 2010
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL energy is focused on in order to break kidney stones and this energy can be varied in size from a narrow (or small) focal zone to a wide (or large) focal zone. This is a multi-centered, randomized study comparing the single treatment success rates of narrow and wide focal zones during SWL.


Condition Intervention
Kidney Stones
Procedure: SWL: Shock Wave Lithotripsy Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentred, Randomized Control Trial Comparing Narrow Versus Wide Focal Zones for Shock Wave Lithotripsy of Renal Calculi

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • SWL efficiency quotient comparison between narrow focus vs wide focus [ Time Frame: 2 and 12 weeks ] [ Designated as safety issue: No ]
    Comparison of single-treatment lithotripsy success rates at 2 and 12 weeks post-lithotripsy. Successful treatment will be defined as either stone-free status or presence of clinically insignificant asymptomatic residual fragments ≤ 4 mm. SWL efficiency quotient for the treatment groups, as calculated by the standardized formula: % stone-free divided by (100 + % re-treated + % auxiliary procedures).


Secondary Outcome Measures:
  • Incidence of perirenal hematomas [ Time Frame: post treatment ] [ Designated as safety issue: No ]
    Comparing the narrow and wide foci for the presence of perirenal hematomas post treatment on ultrasound.

  • Biomarkers for renal injury [ Time Frame: day 0; day 1; 1 week ] [ Designated as safety issue: No ]
    Comparisons of urinary markers for identifying renal injury

  • Time to stone passage [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Time it took to pass the stone for both arms will be compared for the 3 month follow up time.

  • Pain will be compared between narrow vs wide focus arms [ Time Frame: day 0 (post treatment) ] [ Designated as safety issue: No ]
    Visual analog pain scores will be compared between arms.

  • Complication rates [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Complication rates will be compared between narrow and wide focus treatment arms.


Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A (Narrow focus, LP)
A (Narrow focus): stone is in lower pole of kidney and SWL using narrow focus on lithotripter
Procedure: SWL: Shock Wave Lithotripsy Intervention
Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.
Active Comparator: B (Wide focus, LP)
B: stone is in lower pole of kidney and SWL using wide focus on lithotripter
Procedure: SWL: Shock Wave Lithotripsy Intervention
Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.
Active Comparator: C (Narrow focus, no LP)
C: stone is in no-lower pole of kidney and SWL using narrow focus on lithotripter
Procedure: SWL: Shock Wave Lithotripsy Intervention
Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.
Active Comparator: D (Wide focus, no LP)
D: stone is in no-lower pole of kidney and SWL using wide focus on lithotripter
Procedure: SWL: Shock Wave Lithotripsy Intervention
Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.

Detailed Description:

Shock wave lithotripsy (SWL) is a safe and non-invasive treatment for kidney stones. The SWL machine that is currently in use has a unique feature: the focal zone or the energy that the SWL energy is focused on in order to break kidney stones can be varied in size from a narrow (or small) focal zone to a wide (or large) focal zone. Previous lithotripters have only offered one focal size that corresponded to a narrow range. The objective of this study is to compare the single-treatment success rates of narrow and wide focal zones for the shock wave lithotripsy of renal stones between 5 and 15 mm in greatest diameter, while maintaining a constant overall lithotripsy energy level. A wide focal zone may offer some trade-offs when compared with the traditional narrow focal zone: since the area being treated is larger, it is more likely that the stone will receive adequate energy as it moves with patient breathing during treatment, and less energy per cubic inch will be delivered to the kidney around the stone (which might lead to a lower degree of renal injury); on the other hand less energy per cubic inch will also be delivered to the stone, so that stone fragmentation might be inferior to that with a narrow focal zone. Thus, with this study we want to determine whether there is a significant difference in both stone fragmentation and in renal injury (as measured by the incidence of post-treatment renal hematoma or bruises, and by measuring urinary markers indicating the degree of renal cellular damage). Aside from the random choice of focal zone size, there will be no change to the standard of care for lithotripsy treatment. We predict that the narrow focal shock zone will result in superior stone fragmentation, with higher single-treatment stone free and success rates. However, we may identify a slight increased incidence in the rate of subcapsular renal hematoma and renal damage, as detected by urinary markers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stone must be radiopaque on a KUB (kidney ureter bladder) radiograph, and located within the renal collecting system.
  • Patients must have had a CT scan within the past 30 days.
  • Stones must be solitary, between 5 and 15 mm in maximal diameter.
  • Patient must consent to the trial and be willing to return to their respective lithotripsy unit at 2 weeks and 3 months for follow-up.
  • Patients must be treated on the Storz Modulith SLX-F2 machine

Exclusion Criteria:

  • More than one renal calculus on the treated side.
  • Radiolucent stones (uric acid, indinavir) or cystine stones.
  • Stone size < 5 mm and > 15 mm.
  • Previous surgical intervention on upper tracts within past five years.
  • Congenital anatomic anomalies of the kidney, ureters or bladder (such as calyceal diverticulum, horseshoe kidney, etc.)
  • Patient currently taking an α-blocker (alfuzosin, terazosin, doxazosin, tamsulosin, prazosin), calcium channel blocker (verapamil, diltiazem, nifedipine, nicardipine, bepridil, mibefradil), or corticosteroids.
  • Pregnancy.
  • Age < 18 years.
  • Active urinary tract infection.
  • Patient exceed weight limit for SWL table (>500 lbs)
  • Previous SWL treatment for this stone.
  • Uncorrected coagulopathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226875

Contacts
Contact: Daniela Ghiculete, MSc 416-864-6060 ext 6344 ghiculeted@smh.ca

Locations
Canada, British Columbia
Vancouver General Hospital, Jim Pattison Pavilion G floor station 5 GI/GU Lithotripsy suite Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Olga Arsovska, BSc    6048754111 ext 62421    olga.arsovska@ubc.ca   
Principal Investigator: Ben Chew, MD, FRCSC         
Sub-Investigator: Ryan Paterson, MD, FRCSC         
Canada, Ontario
St. Joseph's Hospital, University of Western Ontario Recruiting
London, Ontario, Canada
Contact: Linda Nott, RN    519-646-6100 ext 64885    Linda.Nott@sjhc.london.on.ca   
Principal Investigator: Hassan Razvi         
Sub-Investigator: John D Denstedt, MD         
Sub-Investigator: Stephen E Pautler, MD         
St. Michael's Hospital, University of Toronto, Toronto, Lithotripsy suite, 5th floor Cardinal Carter North Wing Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Daniela Ghiculete, MD, MSc    416-864-6060 ext 6344    ghiculeted@smh.ca   
Principal Investigator: R. John D'A Honey, MA, MB, FRCSC         
Principal Investigator: Kenneth Pace, MD, MSc, FRCSC         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
University of Toronto
University of Western Ontario, Canada
University of British Columbia
Investigators
Principal Investigator: John Honey, MD St. Michael's Hospital, University of Toronto
Principal Investigator: Ken Pace, MD St. Michael's Hospital, University of Toronto
Principal Investigator: Ben Chew, MD University of British Columbia - Vancouver Coastal Health Research Institute
Principal Investigator: Ryan Paterson, MD University of British Columbia - Vancouver Coastal Health Research Institute
Principal Investigator: Hassan Razvi, MD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01226875     History of Changes
Other Study ID Numbers: 10-225
Study First Received: October 20, 2010
Last Updated: February 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
SWL
kidney stones
renal calculi

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

ClinicalTrials.gov processed this record on April 22, 2014