"Dusting" Versus "Basketing" - Treatment Of Intrarenal Stones
Ureteroscopic Treatment of Intrarenal Stones - A Comparative Analysis of "Dusting" Versus "Basketing" With Holmium Laser Lithotripsy
1 other identifier
observational
178
2 countries
9
Brief Summary
The purpose of this study is to evaluate outcomes of an established procedure for treatment of kidney stones that are present within the inner aspect of the kidney. This procedure is called flexible ureteroscopy, which involves placing a small camera through the urethra while anesthetized (asleep), up the ureter (the tube connecting kidney and bladder) and into the kidney to the kidney stone. Then, the stone is broken into tiny fragments using a small laser called a Holmium laser. While this treatment is a well-established option for treatment of these stones, there are several different techniques used to help eliminate them from the kidney. Some urologists treat the stone by a method called "active" extraction whereby the ureteroscope is passed back and forth into the kidney to remove all visible stone fragments. Others use a method called "dusting" whereby the stones are broken into tiny fragments or "dust" with the intention that achieving such a small stone size will allow the stones to pass spontaneously. There has not been a systematic and rigorous comparison of these techniques in terms of treatment outcomes. By collecting information on the success of treatment, the investigators hope to provide benchmark data for future studies of kidney stone treatment and improve the care of all patients who need surgery for their kidney stones. The investigators hypothesize that the stone free rate for renal stone(s) 5-15 mm is around 90% and that the stone clearance rate with be 20% higher in those patients that undergo complete stone fragment extraction versus those that undergo stone dusting (residual fragments \< 2mm).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2013
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 14, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2017
CompletedSeptember 18, 2018
September 1, 2018
4 years
June 12, 2012
September 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stone-free rate
To assess for stone-free rate using K.U.B. (kidney-ureter-bladder) plain radiograph and renal ultrasound. If there is a discrepancy in follow up imaging between the presence of residual stones or fragments between the KUB and renal ultrasound, the KUB will be considered the reference standard for small fragments less than 4mm unless the stone composition is uric acid. If fragments 5 mm or larger exist it will be up to the discretion of the surgeon to order a CT to better delineate the presence of residual stones and their impact on the clinical management of that patient.
4-6 weeks post-operatively
Secondary Outcomes (2)
Stone recurrence rate
12 months post operatively
Retreatment rate
12 months post operatively
Study Arms (2)
Fragments basketed
"Active" extraction is whereby the ureteroscope is passed back and forth into the kidney to remove all visible stone fragments.
Fragments dusted
"Dusting" is whereby the stones are broken into tiny fragments or "dust" with the intention that achieving such a small stone size will allow the stones to pass spontaneously.
Eligibility Criteria
Patients will be identified at clinic visit or hospital admission
You may qualify if:
- Radiopaque renal stones above the level of the ureteropelvic junction
- Patient must be a suitable operative candidate for flexible ureteroscopy
You may not qualify if:
- Patients who have had prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
- Patients who have undergone prior radiotherapy to the abdomen or pelvis and those who have a neurogenic bladder or spinal cord injury
- Pregnant subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (9)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
UCSD
San Diego, California, 92103, United States
James Buchanan Brady Urological Institute
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Bellevue Hospital
New York, New York, 10016, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, 37232, United States
University of British Columbia
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell Humphreys, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant - Urology (surgical)/Associate Professor of Urology
Study Record Dates
First Submitted
June 12, 2012
First Posted
June 14, 2012
Study Start
April 1, 2013
Primary Completion
March 22, 2017
Study Completion
June 10, 2017
Last Updated
September 18, 2018
Record last verified: 2018-09