Bilateral Percutaneous Nephrolithomy

NCT03924362 | Unknown DMC

• 1 other identifier: H19-00426
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effective regimen for definitive surgical therapy of bilateral kidney stones. It is unknown whether patients who undergo simultaneous bilateral percutaneous nephrolithotomy (PCNL) experience improved post-operative outcomes compared to patients who have staged unilateral procedures.

Conditions

Nephrolithiasis of Both Kidneys

Outcome Measures

Primary Outcomes (2)

• Stone Free Rates Measured using Chi-Square analysis.

  Rate of clearance of kidney stones following the procedure.

  3 months.

• Number of Participants with Repeat procedures

  Number of Participants requiring repeat surgical procedures for residual stones following initial treatment.

  3 months.

Secondary Outcomes (3)

• Length of hospital stay

  3 months.

• Number of Participants with Complications

  3 months.

• Patient Quality of Life

  3 months.

Study Arms (2)

Simultaneous Bilateral PCNL

ACTIVE COMPARATOR

Patients undergo simultaneous bilateral PCNL.

Procedure: PCNL

Unilateral PCNL

ACTIVE COMPARATOR

Patients undergoing unilateral staged PCNL.

Procedure: PCNL

Interventions

PCNL PROCEDURE

Percutaneous Nephrolithotomy is a means of treating large kidney stone burdens.

Simultaneous Bilateral PCNL; Unilateral PCNL

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• Any patient with bilateral stone burden eligible and appropriate for PCNL procedure
• Medically fit for definitive surgical management of stone.

You may not qualify if:

• Patients with any of the following characteristics will not be eligible for the present study:
• Those with medical comorbidities preventing them from safely undergoing definitive surgical therapy.
• Patients who are unable to provide informed consent.
• Patients who are planned for alternative procedures (ureteroscopy, extracorporeal shock wave lithotripsy)
• Anyone who is unable to give their informed consent
• Anyone under the age of 19
• Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

Related Publications (6)

• 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

• Jones P, Dhliwayo B, Rai BP, Mokete M, Amitharaj R, Aboumarzouk OM, Somani BK. Safety, Feasibility, and Efficacy of Bilateral Synchronous Percutaneous Nephrolithotomy for Bilateral Stone Disease: Evidence from a Systematic Review. J Endourol. 2017 Apr;31(4):334-340. doi: 10.1089/end.2016.0851. Epub 2017 Mar 22.

  PMID: 28326800 BACKGROUND

• Kang SK, Cho KS, Kang DH, Jung HD, Kwon JK, Lee JY. Systematic review and meta-analysis to compare success rates of retrograde intrarenal surgery versus percutaneous nephrolithotomy for renal stones >2 cm: An update. Medicine (Baltimore). 2017 Dec;96(49):e9119. doi: 10.1097/MD.0000000000009119.

  PMID: 29245347 BACKGROUND

• Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Sur RL, Pais VM Jr, Chew BH, Bird VG, Nakada SY. Validation and Reliability of the Wisconsin Stone Quality of Life Questionnaire. J Urol. 2017 May;197(5):1280-1288. doi: 10.1016/j.juro.2016.11.097. Epub 2016 Nov 23.

  PMID: 27889419 BACKGROUND

• Silverstein AD, Terranova SA, Auge BK, Weizer AZ, Delvecchio FC, Pietrow PK, Munver R, Albala DM, Preminger GM. Bilateral renal calculi: assessment of staged v synchronous percutaneous nephrolithotomy. J Endourol. 2004 Mar;18(2):145-51. doi: 10.1089/089277904322959770.

  PMID: 15072621 BACKGROUND

• Wang CJ, Chang CH, Huang SW. Simultaneous bilateral tubeless percutaneous nephrolithotomy of staghorn stones: a prospective randomized controlled study. Urol Res. 2011 Aug;39(4):289-94. doi: 10.1007/s00240-010-0342-x. Epub 2010 Dec 16.

  PMID: 21161650 BACKGROUND

Study Officials

• Ben Chew, MD

  University of British Columbia, Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Wong

CONTACT

604-875-4111; kfvwong@alumni.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients will be managed either with simultaneous bilateral procedures or staged unilateral procedures based on surgeon's routine practice pattern. Additional surgical interventional will be dependent on initial patient stone-free outcomes.

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 23, 2019
• Study Start: September 30, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)