Bilateral Percutaneous Nephrolithomy

Nephrolithiasis of Both Kidneys Clinical Trial

Official title:

A Prospective Trial of Feasibility and Efficacy of Simultaneous Bilateral Percutaneous Nephrolithotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03924362
• Other study ID #: H19-00426
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: Victor Wong
• Phone: 604-875-4111
• Email: kfvwong[@]alumni.ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Nephrolithiasis of Both Kidneys

Intervention

Procedure:
• PCNL
Percutaneous Nephrolithotomy is a means of treating large kidney stone burdens.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone Free Rates Measured using Chi-Square analysis.	Rate of clearance of kidney stones following the procedure.	3 months.
Primary	Number of Participants with Repeat procedures	Number of Participants requiring repeat surgical procedures for residual stones following initial treatment.	3 months.
Secondary	Length of hospital stay	Hospital stay for simultaneous bilateral versus staged PCNL.	3 months.
Secondary	Number of Participants with Complications	Number of participants with perioperative complication and rates for each procedure.	3 months.
Secondary	Patient Quality of Life	Quality of life assessment comparing the two different procedures will be conducted with the Wisconsin Stone Quality of Life questionnaire (WISQOL). WISQOL is a disease-specific, health-related quality of life measure designed for patients who form kidney stones. This questionnaire has 4 different domains: social-domain 1, emotional-domain 2, stone related-domain 3 and vitality-domain 4. In the questionnaire, patients are to answer between 1 (Very true) to 5 (Not true at all). 1 is the worst outcome, and 5 is the best outcome.	3 months.