UrolithiasisNCT01792765
Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach
A study testing Ultrasound guidance in people with Urolithiasis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Kidney stones are very common, and can inflict a significant degree of pain and renal damage. Some stones become obstructed in the ureter, the tube that drains the kidney. In order to remove these stones, an Urologist and their team use fluoroscopic guidance to do so, this involves continuous X-ray. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Ultrasound guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2014
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Selection criteria will include adult patients with mid and distal ureteral stones ≤8mm, and will be stented prior to presenting for their intervention. Ureteral stenting prior to ureteroscopy is the standard at Dartmouth Hitchcock Medical Center, and both the test and control group will be stented for two weeks prior to their procedure. Initial ureteral stenting will be performed using conventional fluoroscopy at the discretion of the surgeon as this may be in the acute setting and not within the scope of this trial. The mid and distal portion of the ureter refers to the segment of ureter that extends from the upper portion of the sacrum distally to the bladder.
Who cannot join
- Patients will be excluded from the trial if they have had surgical resection involving the bladder or ureter, or a history of known ureteral stricture. Also, this is only for adult patients (>18yo).
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Kidney stones are very common, and can inflict a significant degree of pain and renal damage. Some stones become obstructed in the ureter, the tube that drains the kidney. In order to remove these stones, an Urologist and their team use fluoroscopic guidance to do so, this involves continuous X-ray. Flouroscopy delivers a significant dose of radiation to the patient, as well as the health care team, which has been shown to have serious health consequences. Previous studies have shown that in certain populations, like pregnant women, stones can be managed using ultrasound guidance. The investigators propose that mid and distal ureteral stones could be managed using ultrasound guidance in conjunction with conventional stone removal techniques (ureteroscopy, lithotripsy, and ureteral stent placement), in lieu of fluoroscopy, thereby minimizing radiation to healthcare staff and patients.
The investigators hypothesize that distal ureteral stones can be identified and efficiently fragmented and removed under ultrasound guidance in a safe and effective manner without the use of radiation.
Read the detailed description
Patients will be enrolled and consented for this study in our Urology Clinic at Dartmouth Hitchcock Memorial Hospital and randomized prospectively to fluoroscopic versus ultrasound guided groups. A computer randomization program will be used to randomize the patient to the test or control group. Randomization will take place after they have consented to participate in the study, and the case will be booked accordingly. Consent to participate in this study will be obtained at the patient's followup appointment. At the time of the initial clinical encounter they will be provided with the consent form and information regarding the study. Once they have had the chance to look this over they will be contacted about whether they would consent to be in the study. If so, they will be randomized and the consent form signed on the morning of the procedure. Each group will consist of 25 patients. This pilot group size was determined based on feasibility of recruitment in the study period and funding availability.
All patients will receive preoperative antibiotics selected in accordance to their previous urine culture sensitivities and their respective allergies where applicable. Intraoperatively, all patients will be placed in the dorsal lithotomy position. All patients will be under general anesthesia, in both treatment arms, this is standard of care. All procedures will begin with standard cystourethroscopy, removal of the previous ureteral stent, and passage of a wire proximally into the renal pelvis. The ultrasound group will undergo intraoperative transabdominal ultrasonography by a designated ultrasonographer, and the presence of the wire, and later the ureteral stent, within the renal pelvis will be confirmed via ultrasound in all patients. The control group will undergo standard verification of wire and stent placement via fluoroscopy. Operative time as well as radiation fluoroscopy time will be recorded and compared between the two groups. At our institution, this procedure is scheduled for 140 minutes of OR time based on previous experience by our group and this individual surgeon. Stone free rate will be determined at one month post operatively with a KUB and renal ultrasound and compared between groups.
Intraoperatively, if there is concern for poor visualization, lack of progress, or technical difficulty related to the use of intraoperative ultrasound, or any other safety concerns, then this technique will be abandoned and conventional fluoroscopy will be used for this patient group. This will be apparent in the first 15 - 30 minutes of the procedure.
- Conditions
- Urolithiasis
- Being tested
- Ultrasound guidance
- Keywords
- urolithiasis, radiation free, ultrasound guidance, ureteroscopy
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guidanceOther
Also called Ultrasound transducer
Patient will have intraoperative ultrasound .
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | This arm will undergo ureteroscopy using conventional fluoroscopy to guide the procedure and visualize scope position, safety wire status, etc. |
| Ultrasound guidance | Experimental | This arm will have intraoperative ultrasound guidance to determine safety wire position and for scope guidance. Receives: Other: Ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ultrasound guided ureteroscopy
We assess to see if patients had any intraoperative complications during this study, or have any post operative complications as a result of their treatment.
Measured: Day1
Secondary outcomes (1)
To assess the efficacy of ultrasound guided ureteroscopy for management of distal ureteral stones.
We determine if we can render patients stone free using this novel method. We also determine if this is a viable option to introduce into the OR in terms of use of operative time, which is the most expensive variable when looking at this individual urologic procedure.
Measured: post operatively at 4-6wks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startOct 2011
- Primary completionAug 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vernon M Pais, MD, Principal investigator, Assistant Professor at Dartmouth Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792765
- Sponsor's protocol ID
- 22487 (CPHS)
- Status last verified
- Feb 2015
- First submitted
- 11 Feb 2013
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach
- ClinicalTrials.gov ID
- NCT01792765
- Acronym / sponsor ID
- 22487 (CPHS)
- Conditions
- Urolithiasis
- Keywords
- urolithiasis, radiation free, ultrasound guidance, ureteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kidney stones are very common, and can inflict a significant degree of pain and renal damage. Some stones become obstructed in the ureter, the tube that drains the kidney. In order to remove these stones, an Urologist and their team use fluoroscopic guidance to do so, this involves continuous X-ray. Flouroscopy delivers a significant dose of radiation to the patient, as well as the health care team, which has been shown to have serious health consequences. Previous studies have shown that in certain populations, like pregnant women, stones can be managed using ultrasound guidance. The investigators propose that mid and distal ureteral stones could be managed using ultrasound guidance in conjunction with conventional stone removal techniques (ureteroscopy, lithotripsy, and ureteral stent placement), in lieu of fluoroscopy, thereby minimizing radiation to healthcare staff and patients.
The investigators hypothesize that distal ureteral stones can be identified and efficiently fragmented and removed under ultrasound guidance in a safe and effective manner without the use of radiation.
Detailed description
Patients will be enrolled and consented for this study in our Urology Clinic at Dartmouth Hitchcock Memorial Hospital and randomized prospectively to fluoroscopic versus ultrasound guided groups. A computer randomization program will be used to randomize the patient to the test or control group. Randomization will take place after they have consented to participate in the study, and the case will be booked accordingly. Consent to participate in this study will be obtained at the patient's followup appointment. At the time of the initial clinical encounter they will be provided with the consent form and information regarding the study. Once they have had the chance to look this over they will be contacted about whether they would consent to be in the study. If so, they will be randomized and the consent form signed on the morning of the procedure. Each group will consist of 25 patients. This pilot group size was determined based on feasibility of recruitment in the study period and funding availability.
All patients will receive preoperative antibiotics selected in accordance to their previous urine culture sensitivities and their respective allergies where applicable. Intraoperatively, all patients will be placed in the dorsal lithotomy position. All patients will be under general anesthesia, in both treatment arms, this is standard of care. All procedures will begin with standard cystourethroscopy, removal of the previous ureteral stent, and passage of a wire proximally into the renal pelvis. The ultrasound group will undergo intraoperative transabdominal ultrasonography by a designated ultrasonographer, and the presence of the wire, and later the ureteral stent, within the renal pelvis will be confirmed via ultrasound in all patients. The control group will undergo standard verification of wire and stent placement via fluoroscopy. Operative time as well as radiation fluoroscopy time will be recorded and compared between the two groups. At our institution, this procedure is scheduled for 140 minutes of OR time based on previous experience by our group and this individual surgeon. Stone free rate will be determined at one month post operatively with a KUB and renal ultrasound and compared between groups.
Intraoperatively, if there is concern for poor visualization, lack of progress, or technical difficulty related to the use of intraoperative ultrasound, or any other safety concerns, then this technique will be abandoned and conventional fluoroscopy will be used for this patient group. This will be apparent in the first 15 - 30 minutes of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –This arm will undergo ureteroscopy using conventional fluoroscopy to guide the procedure and visualize scope position, safety wire status, etc. |
| Ultrasound guidance | Experimental | Other: Ultrasound guidanceThis arm will have intraoperative ultrasound guidance to determine safety wire position and for scope guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Selection criteria will include adult patients with mid and distal ureteral stones ≤8mm, and will be stented prior to presenting for their intervention. Ureteral stenting prior to ureteroscopy is the standard at Dartmouth Hitchcock Medical Center, and both the test and control group will be stented for two weeks prior to their procedure. Initial ureteral stenting will be performed using conventional fluoroscopy at the discretion of the surgeon as this may be in the acute setting and not within the scope of this trial. The mid and distal portion of the ureter refers to the segment of ureter that extends from the upper portion of the sacrum distally to the bladder.
Key exclusion criteria (1 listed)
- Patients will be excluded from the trial if they have had surgical resection involving the bladder or ureter, or a history of known ureteral stricture. Also, this is only for adult patients (>18yo).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guidanceAlso: Ultrasound transducerPatient will have intraoperative ultrasound . | Other | Ultrasound guidance |
Primary outcome
Safety of ultrasound guided ureteroscopy
Time frame: Day1
We assess to see if patients had any intraoperative complications during this study, or have any post operative complications as a result of their treatment.
1 secondary outcome
To assess the efficacy of ultrasound guided ureteroscopy for management of distal ureteral stones.
Time frame: post operatively at 4-6wks post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vernon M Pais, MD principal investigator
Assistant Professor at Dartmouth Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guidance in people with Urolithiasis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 1 inclusion and 1 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 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Safety of ultrasound guided ureteroscopy (time frame: Day1). 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 10 Feb 2015.