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

NCT01792765 | Completed DMC

• 1 other identifier: 22487 (CPHS)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Urolithiasis

Keywords

urolithiasis; radiation free; ultrasound guidance; ureteroscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  Day1

Secondary Outcomes (1)

• To assess the efficacy of ultrasound guided ureteroscopy for management of distal ureteral stones.

  post operatively at 4-6wks post op

Study Arms (2)

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.

Other: Ultrasound guidance

Interventions

Ultrasound guidance OTHER

Patient will have intraoperative ultrasound .

Also known as: Ultrasound transducer

Ultrasound guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Vernon M Pais, MD

  Assistant Professor at Dartmouth Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 15, 2013
• Study Start: October 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2014
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

US (1)