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Kidney CalculiNCT01619735

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

An observational study of Kidney Calculi and Kidney Stones, run by Mayo Clinic at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Calculi, Kidney Stones, Nephrolithiasis
How many people
178 participants
Where
9 sitesin 2 countries
Study dates
Apr 2013to 10 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be identified at clinic visit or hospital admission

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States8 sites
  • James Buchanan Brady Urological Institute

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • Vanderbilt University School of Medicine

    Nashville, Tennessee, 37232

  • Bellevue Hospital

    New York, New York, 10016

  • UCSD

    San Diego, California, 92103

  • Mayo Clinic

    Scottsdale, Arizona, 85259

Other trials in United States

Canada1 site
  • University of British Columbia

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: Ureteroscopic Treatment of Intrarenal Stones - A Comparative Analysis of "Dusting" Versus "Basketing" With Holmium Laser Lithotripsy

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).

Read the 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.

Keywords
Kidney Calculi, Kidney Stones, Nephrolithiasis, Renal Stones
Medical subject headings
Kidney Calculi, Nephrolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01619735
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4-6 weeks post-operatively

Secondary outcomes (2)
  1. Stone recurrence rate

    Stone recurrence rate one year after surgery

    Measured: 12 months post operatively

  2. Retreatment rate

    Evaluating the retreatment rate one year post operation

    Measured: 12 months post operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2012 (estimated)
  2. Study startApr 2013
  3. Primary completion22 Mar 2017
  4. Study completion10 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01619735
Sponsor's protocol ID
12-002553
Status last verified
Sep 2018
First submitted
12 Jun 2012
Last updated
18 Sep 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Calculi and Kidney Stones, run by Mayo Clinic at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stone-free rate (time frame: 4-6 weeks post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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