Nephrolithiasis of Both KidneysNCT03924362
Bilateral Percutaneous Nephrolithomy
A study testing PCNL in people with Nephrolithiasis of Both Kidneys, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nephrolithiasis of Both Kidneys
- What is being tested?
- PCNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects with a clinical diagnosis of struvite calculi will potentially be included. Specific inclusion criteria include the following:
- Age >18 years
- Any patient with bilateral stone burden eligible and appropriate for PCNL procedure
- Medically fit for definitive surgical management of stone.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia, V5Z1M9
Victor Wong, BSc, 6048754111 ext. 62421, victor.kf.wong@ubc.ca
Ben H Chew, MD
About this study
Official title: A Prospective Trial of Feasibility and Efficacy of Simultaneous Bilateral Percutaneous Nephrolithotomy
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.
Read the 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
- stone free rates
- re-intervention rates for residual stones and
- perioperative complication rates
Objectives
The objectives are:
- To provide clinical data on outcomes following simultaneous bilateral and staged percutaneous nephrolithotomy for renal and ureteral calculi
- 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.
- Conditions
- Nephrolithiasis of Both Kidneys
- Being tested
- PCNL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCNLProcedure or surgery
Percutaneous Nephrolithotomy is a means of treating large kidney stone burdens.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous Bilateral PCNL | Active comparator | Patients undergo simultaneous bilateral PCNL. Receives: Procedure: PCNL |
| Unilateral PCNL | Active comparator | Patients undergoing unilateral staged PCNL. Receives: Procedure: PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone Free Rates Measured using Chi-Square analysis.
Rate of clearance of kidney stones following the procedure.
Measured: 3 months.
Number of Participants with Repeat procedures
Number of Participants requiring repeat surgical procedures for residual stones following initial treatment.
Measured: 3 months.
Secondary outcomes (3)
Length of hospital stay
Hospital stay for simultaneous bilateral versus staged PCNL.
Measured: 3 months.
Number of Participants with Complications
Number of participants with perioperative complication and rates for each procedure.
Measured: 3 months.
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.
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start30 Sep 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nephrolithiasis of Both KidneysStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
- Investigators
- Ben Chew, MD, Principal investigator, University of British Columbia, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924362
- Sponsor's protocol ID
- H19-00426
- Status last verified
- May 2022
- First submitted
- 26 Mar 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The University of British Columbia is the main site of the study, therefore all data will be transferred from the subsites to the University of British Columbia, and no transfer of data to the subsites. Any data transfer will be de-identified.
Publications
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.
PubMed 27238615Jones 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.
PubMed 28326800Kang 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.
PubMed 29245347Penniston 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.
PubMed 27889419Silverstein 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.
PubMed 15072621Wang 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.
PubMed 21161650
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Feasibility and Efficacy of Simultaneous Bilateral Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT03924362
- Acronym / sponsor ID
- H19-00426
- Conditions
- Nephrolithiasis of Both Kidneys
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- stone free rates
- re-intervention rates for residual stones and
- perioperative complication rates
Objectives
The objectives are:
- To provide clinical data on outcomes following simultaneous bilateral and staged percutaneous nephrolithotomy for renal and ureteral calculi
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Simultaneous Bilateral PCNL | Active comparator | Procedure: PCNLPatients undergo simultaneous bilateral PCNL. |
| Unilateral PCNL | Active comparator | Procedure: PCNLPatients undergoing unilateral staged PCNL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All subjects with a clinical diagnosis of struvite calculi will potentially be included. Specific inclusion criteria include the following:
- Age >18 years
- Any patient with bilateral stone burden eligible and appropriate for PCNL procedure
- Medically fit for definitive surgical management of stone.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCNLPercutaneous Nephrolithotomy is a means of treating large kidney stone burdens. | Procedure or surgery | Simultaneous Bilateral PCNL, Unilateral PCNL |
Primary outcome
Stone Free Rates Measured using Chi-Square analysis.
Time frame: 3 months.
Rate of clearance of kidney stones following the procedure.
Number of Participants with Repeat procedures
Time frame: 3 months.
Number of Participants requiring repeat surgical procedures for residual stones following initial treatment.
3 secondary outcomes
Length of hospital stay
Time frame: 3 months.
Number of Participants with Complications
Time frame: 3 months.
Patient Quality of Life
Time frame: 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 27238615Assimos 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.
- Background: PubMed 28326800Jones 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.
- Background: PubMed 29245347Kang 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.
- Background: PubMed 27889419Penniston 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.
- Background: PubMed 15072621Silverstein 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.
- Background: PubMed 21161650Wang 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.
- Individual participant dataSharing planned: No. The University of British Columbia is the main site of the study, therefore all data will be transferred from the subsites to the University of British Columbia, and no transfer of data to the subsites. Any data transfer will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Chew, MD principal investigator
University of British Columbia, Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCNL in people with Nephrolithiasis of Both Kidneys, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victor Wong (604-875-4111 ext. 62421, kfvwong@alumni.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone Free Rates Measured using Chi-Square analysis. (time frame: 3 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03924362, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.