Accuracy of Ultrasound for Detecting Residual Fragments During RIRS

NCT ID: NCT05535816

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2024-12-18

Brief Summary

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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.

Detailed Description

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Ultrasound is currently gaining popularity as an alternative imaging modality for the diagnosis and treatment of urolithiasis. However, the benefit of ultrasound on the diagnostic accuracy of detecting residual fragments during retrograde intrarenal surgery (RIRS) has never been evaluated in a randomized study. Its use would reduce radiation exposure for patients and care team members as well as improve stone free clearance rates for surgery. Therefore, The investigators plan to conduct a randomized trial to assess the diagnostic accuracy of ultrasound and fluoroscopy in conjunction with endoscopic examination for detecting residual stone fragments during retrograde intrarenal surgery. After admission, approximately 172 subjects will be randomized in a 1:1 ratio to receive ultrasound or fluoroscopy before completing RIRS. Subsequently, four weeks after the operation, the investigators will compare with routine low-dose non-contrast computed tomography as a gold standard for detecting residual fragments. If ultrasound is more accurate than fluoroscopy in detecting residual fragments, the investigators will encourage this approach as it can reduce radiation exposure for patients and healthcare professionals.

Conditions

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Stone, Kidney Ultrasound Therapy; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound

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.

Group Type EXPERIMENTAL

Ultrasound

Intervention Type 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.

Fluoroscopy

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Chi, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27238615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26344917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31304880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30398369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27578040 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27733052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23073063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29239803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20206970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28341578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29476214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15273542 (View on PubMed)

Other Identifiers

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22-37292

Identifier Type: -

Identifier Source: org_study_id

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