"Dusting" Versus "Basketing" - Treatment Of Intrarenal Stones

This study is currently recruiting participants.
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Mitchell Humphreys, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01619735
First received: June 12, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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).


Condition
Kidney Calculi
Kidney Stones
Nephrolithiasis
Renal Stones

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ureteroscopic Treatment of Intrarenal Stones - A Comparative Analysis of "Dusting" Versus "Basketing" With Holmium Laser Lithotripsy

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Stone-free rate [ Time Frame: 4-6 weeks post-operatively ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Stone recurrence rate [ Time Frame: 12 months post operatively ] [ Designated as safety issue: No ]
    Stone recurrence rate one year after surgery

  • Retreatment rate [ Time Frame: 12 months post operatively ] [ Designated as safety issue: No ]
    Evaluating the retreatment rate one year post operation


Estimated Enrollment: 150
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

To date, there is inadequate literature to confidently determine the ideal technique of stone extraction during ureteroscopy, an endourologic procedure for the treatment of kidney stones. The goals of ureteroscopy for intrarenal stones are to fragment stones and minimize residual fragments while doing so in a safe and expeditious way with minimal harm to the patient. Options for the treatment of intrarenal stones consist of using a basket to pull them out or a laser to break them into small fragments. When stones are deemed too large to be basketed primarily, the standard preference in ureteroscopic laser lithotripsy is use of the Holmium:YAG laser which can effectively break stones into fragments small enough to remove or pass spontaneously.

There is no consensus on how to achieve optimal stone clearance once the primary stone is fragmented with lithotripsy. Many urologists choose to &quot;dust&quot; the stone by breaking it into tiny fragments &lt; 1 - 2 mm in size with the assumption that stone fragments of such a small size will pass spontaneously after surgery. This can theoretically decrease operative times and lower risk of ureteral trauma by minimizing repetitive introduction and removal of the ureteroscope. Others choose to actively extract each possible stone fragment during the procedure thereby increasing the immediate stone-free outcome.

Active extraction however typically increases costs as it requires use of a basket or grasper and ureteral access sheath. To date, only one prospective, randomized study has addressed the practice of active extraction vs spontaneous passage, the results of which suggested higher rates of residual stone fragments, hospital readmissions and need for ancillary procedures when stones were not actively extracted (8). This study was criticized for not following a standardized operative protocol and not reporting several important outcomes including stone composition. Additionally, this study used semirigid ureteroscopy, specifically addressed ureteral rather than intrarenal stones, and did not follow a "dusting" protocol assuring minimal size of residual fragments.

Complete eradication of stone fragments is one of the primary outcomes of ureteroscopy as residual renal stone fragments after ureteroscopy have been shown to lead to a subsequent stone event in approximately 20% of cases(9). However, maximizing eradication of stone fragments must not come at the expense of the patient. For this reason it is important to consider the operative variables associated with the different techniques employed to clear stone during such procedures.

For example, an average of nearly three times as much laser energy was used to fragment the stone into tiny pieces compared to active extraction (8). Conversely, active extraction of stone fragments requires introducing and removing the ureteroscope through the ureter a greater number of times in order to facilitate stone removal; which generally requires use of a ureteral access sheath, a treatment with its own associated risk.(10). The short term and long term differences resulting from use of these techniques is currently unknown.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be identified at clinic visit or hospital admission

Criteria

Inclusion Criteria:

  • Radiopaque renal stones above the level of the ureteropelvic junction
  • Kidney stones must range up to 20 mm in size or in the case of multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm is required for inclusion
  • Patient must be a suitable operative candidate for flexible ureteroscopy

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619735

Locations
United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Andre Watkins       watkins.andre@mayo.edu   
Principal Investigator: Mitchell R Humphreys, MD         
United States, California
UCSD Recruiting
San Diego, California, United States, 92103
Contact: Roger Sur, MD    619-543-2628      
Principal Investigator: Roger Sur, MD         
United States, Maryland
James Buchanan Brady Urological Institute Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Brian Matlaga, MD, MPH    410-502-7710    bmatlagq@jhmi.edu   
Principal Investigator: Brian Matlaga, MD, MPH         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Brian Eisner, MD    617-726-2000    beisner@partners.org   
Principal Investigator: Brian Eisner, MD         
United States, New Hampshire
Dartmouth University Not yet recruiting
Hanover, New Hampshire, United States, 03755
Contact: Vernon M Pais, MD       Vernon.M.Pais.Ju@hitchcock.org   
Principal Investigator: Vernon M Pais, MD         
United States, New York
Bellevue Hospital Recruiting
New York, New York, United States, 10016
Contact: Ojas Shah, MD    646-825-6322    Ojas.Shah@nyumc.org   
Contact: Laurie Mantor    646-825-6328    laurie.mantor@nyumc.org   
Principal Investigator: Ojas Shah, MD         
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Lipkin, MD    919-681-5506    michael.lipkin@duke.edu   
Principal Investigator: Michael Lipkin, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Carl Sarkissian       sarkisc@ccf.org   
Principal Investigator: Manoj Monga, MD, FACS         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Andrea Inman    614-688-6658    andrea.inman@osumc.edu   
Contact: Janet McGarr    614-366-1662    Janet.Mcgarr@osumc.edu   
Principal Investigator: Bodo Knudsen, MD         
United States, Tennessee
Vanderbilt University School of Medicine Recruiting
Nashville, Tennessee, United States, 37232
Contact: Nicole Miller, MD    615-322-5000    Nicole.miller@Vanderbilt.Edu   
Contact: Ryan Pickens       ryan.pickens@vanderbilt.edu   
Principal Investigator: Nicole Miller, MD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada
Contact: Ben Chew, MD    (604)875-4818    Ben.chew@ubc.ca   
Contact: Olga Arsovska       olga555@mail.ubc.ca   
Principal Investigator: Ben Chew, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mitchell Humphreys, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Mitchell Humphreys, Consultant - Urology (surgical)/Associate Professor of Urology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01619735     History of Changes
Other Study ID Numbers: 12-002553
Study First Received: June 12, 2012
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Kidney Calculi
Kidney Stones
Nephrolithiasis
Renal Stones

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 21, 2014