Accuracy of Ultrasound for Detecting Residual Fragments During RIRS

NCT05535816 | Terminated FDA Device

• 1 other identifier: 22-37292
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the accuracy of ultrasound and traditional fluoroscopy to find the residual fragments before retrograde intrarenal surgery is complete. This would ultimately limit the need for radiation exposure and improve the quality of clinical care given to patients and healthcare teams.

Conditions

Stone, Kidney; Ultrasound Therapy; Complications

Keywords

residual stone; ureteroscopy; ultrasound; diagnostic accuracy

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy detecting residual fragments during retrograde intrarenal surgery

  The diagnostic accuracy of ultrasound and fluoroscopy will be measured in conjunction with endoscopic examination for detecting residual fragments during retrograde intrarenal surgery for renal stones treatment by the same endourologist to determine the size of the largest residual fragment, categorizing them as stone free, ≤ 2 mm, or \>2 mm, and compared with routine low-dose non-contrast computed tomography by a radiologist blinded to surgery and intraoperative imaging, categorizing them as stone free, ≤ 2 mm, or \>2 mm. The results will be compared for accuracy.

  4 weeks

Secondary Outcomes (6)

• Sensitivity detecting residual fragments during retrograde intrarenal surgery

  4 weeks

• Specificity detecting residual fragments during retrograde intrarenal surgery

  4 weeks

• Positive predictive value detecting residual fragments during retrograde intrarenal surgery

  4 weeks

• Negative predictive value detecting residual fragments during retrograde intrarenal surgery

  4 weeks

• Operative time in minutes

  Surgical duration, up to 4 hours

Study Arms (2)

Ultrasound

EXPERIMENTAL

Before completing retrograde intrarenal surgery, a complete endoscopic examination will be performed along with ultrasound by the same endourologist to determine the size of the largest residual fragment.

Diagnostic Test: Ultrasound

Fluoroscopy

NO INTERVENTION

Standard of care, control Before completing retrograde intrarenal surgery, a complete endoscopic examination will be performed along with fluoroscopy by the same endourologist to determine the size of the largest residual fragment.

Interventions

Ultrasound DIAGNOSTIC_TEST

Before completing retrograde intrarenal surgery, a complete endoscopic examination will be performed along with ultrasound instead of fluoroscopy by the same endourologist to determine the size of the largest residual fragment.

Ultrasound

Eligibility Criteria

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

You may qualify if:

• Patients over the age of 18.
• Consecutive patients with a diagnosis of renal stone or ureteral stone with a plan to undergoing RIRS for stone removal.

You may not qualify if:

• Patients who decline informed consent.
• Pregnancy
• Kidney transplantation
• Ectopic kidney
• Patients undergoing concurrent bilateral stone removal surgery.
• Patients whose pain cannot be controlled when presenting at the Emergency Department.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (12)

• Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART II. J Urol. 2016 Oct;196(4):1161-9. doi: 10.1016/j.juro.2016.05.091. Epub 2016 May 27.

  PMID: 27238615 BACKGROUND

• Turk C, Petrik A, Sarica K, Seitz C, Skolarikos A, Straub M, Knoll T. EAU Guidelines on Interventional Treatment for Urolithiasis. Eur Urol. 2016 Mar;69(3):475-82. doi: 10.1016/j.eururo.2015.07.041. Epub 2015 Sep 4.

  PMID: 26344917 BACKGROUND

• Prezioso D, Barone B, Di Domenico D, Vitale R. Stone residual fragments: A thorny problem. Urologia. 2019 Nov;86(4):169-176. doi: 10.1177/0391560319860654. Epub 2019 Jul 14.

  PMID: 31304880 BACKGROUND

• Danilovic A, Cavalanti A, Rocha BA, Traxer O, Torricelli FCM, Marchini GS, Mazzucchi E, Srougi M. Assessment of Residual Stone Fragments After Retrograde Intrarenal Surgery. J Endourol. 2018 Dec;32(12):1108-1113. doi: 10.1089/end.2018.0529.

  PMID: 30398369 BACKGROUND

• Brisbane W, Bailey MR, Sorensen MD. An overview of kidney stone imaging techniques. Nat Rev Urol. 2016 Nov;13(11):654-662. doi: 10.1038/nrurol.2016.154. Epub 2016 Aug 31.

  PMID: 27578040 BACKGROUND

• Tzou DT, Usawachintachit M, Taguchi K, Chi T. Ultrasound Use in Urinary Stones: Adapting Old Technology for a Modern-Day Disease. J Endourol. 2017 Apr;31(S1):S89-S94. doi: 10.1089/end.2016.0584. Epub 2016 Nov 3.

  PMID: 27733052 BACKGROUND

• Deters LA, Belanger G, Shah O, Pais VM. Ultrasound guided ureteroscopy in pregnancy. Clin Nephrol. 2013 Feb;79(2):118-23. doi: 10.5414/CN107654.

  PMID: 23073063 BACKGROUND

• Morrison JC, Van Batavia JP, Darge K, Long CJ, Shukla AR, Srinivasan AK. Ultrasound guided ureteroscopy in children: Safety and success. J Pediatr Urol. 2018 Feb;14(1):64.e1-64.e6. doi: 10.1016/j.jpurol.2017.08.019. Epub 2017 Oct 14.

  PMID: 29239803 BACKGROUND

• Ray AA, Ghiculete D, Pace KT, Honey RJ. Limitations to ultrasound in the detection and measurement of urinary tract calculi. Urology. 2010 Aug;76(2):295-300. doi: 10.1016/j.urology.2009.12.015. Epub 2010 Mar 5.

  PMID: 20206970 BACKGROUND

• Kanno T, Kubota M, Funada S, Okada T, Higashi Y, Yamada H. The Utility of the Kidneys-ureters-bladder Radiograph as the Sole Imaging Modality and Its Combination With Ultrasonography for the Detection of Renal Stones. Urology. 2017 Jun;104:40-44. doi: 10.1016/j.urology.2017.03.019. Epub 2017 Mar 21.

  PMID: 28341578 BACKGROUND

• Roberson NP, Dillman JR, O'Hara SM, DeFoor WR Jr, Reddy PP, Giordano RM, Trout AT. Comparison of ultrasound versus computed tomography for the detection of kidney stones in the pediatric population: a clinical effectiveness study. Pediatr Radiol. 2018 Jul;48(7):962-972. doi: 10.1007/s00247-018-4099-7. Epub 2018 Feb 23.

  PMID: 29476214 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Thomas Chi, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: March 27, 2023
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)