Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01792765
First received: February 11, 2013
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Urolithiasis
Other: Ultrasound guidance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Safety of ultrasound guided ureteroscopy [ Time Frame: Day1 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • To assess the efficacy of ultrasound guided ureteroscopy for management of distal ureteral stones. [ Time Frame: post operatively at 4-6wks post op ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Arm
This arm will undergo ureteroscopy using conventional fluoroscopy to guide the procedure and visualize scope position, safety wire status, etc.
Experimental: Ultrasound guidance
This arm will have intraoperative ultrasound guidance to determine safety wire position and for scope guidance.
Other: Ultrasound guidance
Patient will have intraoperative ultrasound .
Other Name: Ultrasound transducer

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792765

Locations
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Vernon M Pais, MD Assistant Professor at Dartmouth Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01792765     History of Changes
Other Study ID Numbers: 22487 (CPHS)
Study First Received: February 11, 2013
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
urolithiasis
radiation free
ultrasound guidance
ureteroscopy

Additional relevant MeSH terms:
Ureteral Calculi
Ureterolithiasis
Urolithiasis
Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Urinary Calculi
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014