Clinical trial NCT03924362: Bilateral Percutaneous Nephrolithomy
Official title: A Prospective Trial of Feasibility and Efficacy of Simultaneous Bilateral Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nephrolithiasis of Both Kidneys
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Purpose:

The aim of this research is to determine an 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.

Hypothesis and Justification The gold standard for surgical management of large kidney stones is percutaneous nephrolithotomy (PCNL). A large renal stone burden has been defined as \>20mm. In addition, PCNL has improved stone-free rates for lower pole calculi \>10mm compared to alternative treatments. Guidelines encourage removal of staghorn calculi for surgical candidates (Assimos et al., 2016). Patients with bilateral large stone burdens have been managed with one of two general options: (i) a single procedure in which both kidneys are operated upon or (ii) two separate procedures in which only one kidney is addressed per procedure. However, there are no prospectively performed peer-reviewed studies directly comparing the two practices. The investigators seek to determine whether there is a significant difference in patient outcomes based on the surgical regimen chosen.

The investigators hypothesize that in comparison to unilateral PCNL (U-PCNL), simultaneous bilateral PCNL (SB-PCNL) under one anesthetic results in comparable

1. stone free rates
2. re-intervention rates for residual stones and
3. perioperative complication rates

Objectives

The objectives are:

1. To provide clinical data on outcomes following simultaneous bilateral and staged percutaneous nephrolithotomy for renal and ureteral calculi
2. To determine patient preference with respect to simultaneous versus staged PCNL

Research Design This study will be a prospective, non-randomized, multi-centre, non-blinded trial. Participants will be accrued through the Vancouver General Hospital Stone Center who have been referred for bilateral stones or have been seen in consultation for bilateral stones at the Department of Urologic Sciences and are scheduled for a percutaneous nephrolithotomy (PCNL). Consent forms and Letters of Introduction outlining the study will be given to patients by a research coordinator once the decision is made to book surgery. Patients will have at least 24 hours to decide to participate. Patients will receive surgical management for their stones in the form of PCNL. A computed tomography (CT) scan of the kidneys will be performed post-operatively by week 6 to determine if any residual stone fragments are present. Patients will be seen in follow up at 3 months in clinic after undergoing a follow up CT KUB, renal ultrasound, or KUB as necessary to evaluate stone clearance.

Eligibility criteria: Inclusion Criteria:

All subjects with a clinical diagnosis of struvite calculi will potentially be included. Specific inclusion criteria include the following:

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

Exclusion Criteria:

Patients with any of the following characteristics will not be eligible for the present study:

1. Those with medical comorbidities preventing them from safely undergoing definitive surgical therapy.
2. Patients who are unable to provide informed consent.
3. Patients who are planned for alternative procedures (ureteroscopy, extracorporeal shock wave lithotripsy)
4. Anyone who is unable to give their informed consent
5. Anyone under the age of 19
6. Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study

Primary outcomes:
measure: Stone Free Rates Measured using Chi-Square analysis.
timeFrame: 3 months.
measure: Number of Participants with Repeat procedures
timeFrame: 3 months.
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 3 months.
measure: Number of Participants with Complications
timeFrame: 3 months.
measure: Patient Quality of Life
timeFrame: 3 months.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia, Associate Professor
name: Ben Chew, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.