Percutaneous NephrolithotomyNCT04943081
Percutaneous Nephrolithotomy in Patients With Stage 2-4 Chronic Kidney Disease
A study testing Percutaneous nephrolithotomy in people with Percutaneous Nephrolithotomy, run by Assiut University.
Trial summary
The study aims to evaluate the effect of percutaneous nephrolithotomy (PCNL) on estimated glomerular filtration rate (eGFR) in patients with stage 2-4 chronic kidney disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- Percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Oct 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with age group ≥ 18 years old with renal stones candidate for PCNL with pre-operative estimated GFR less than 90 ml/min/1.7 m2 and ≥ 15 ml/min/1.7 m2
Who cannot join
- Patients with chronic renal failure on regular dialysis.
- Patients with bleeding diathesis.
- Patients who are unfit for surgery.
- Pregnancy
- Patients who are refusing the participation in our study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Percutaneous Nephrolithotomy on the Estimated Glomerular Filtration Rate in Patients With Stage 2-4 Chronic Kidney Disease
The study aims to evaluate the effect of percutaneous nephrolithotomy (PCNL) on estimated glomerular filtration rate (eGFR) in patients with stage 2-4 chronic kidney disease
Read the detailed description
Nephrolithiasis affects an estimated 5-10% of the general population, and this percentage continues to rise. It has a prevalence of 1.7% to 18% in patients with chronic kidney disease (CKD), and nephrolithiasis-related CKD contributed to 3.2% of the total patients who started maintenance dialysis therapy.
The etiology of renal insufficiency in patients with nephrolithiasis is multifactorial and includes renal obstruction, recurrent urinary tract infections, frequent surgical interventions and coexisting medical disease.
According to National kidney foundation, chronic kidney disease is classified into 5 stages as follows:
Stage 1: Kidney damage with normal or elevated GFR < 90 ml/min/1.7 m2 Stage 2: Kidney damage with mildly decreased GFR 60-89 ml/min/1.7 m2 Stage 3: Moderately decreased GFR 30-59 ml/min/1.7 m2 Stage 4: Severely decreased GFR 15-29 ml/min/1.7 m2 Stage 5: Kidney Failure GFR>15 ml/min/1.7 m2 Management of nephrolithiasis in patients with CKD is often difficult. Options for preserving kidney function include watchful waiting, shockwave lithotripsy (SWL), an endourologic approach (Percutaneous nephrolithotomy or retrograde intra-renal surgery), laparoscopic surgery or conventional open surgery.
Percutaneous nephrolithotomy (PCNL) is considered as the gold standard intervention for large burden and complex renal stone disease and is associated with the highest stone free rates (SFRs). However, potentially significant complications include bleeding, sepsis, pleural and visceral injury. Therefore, the optimal management plan needs to be tailored to individual patient.
Serum creatinine level has been used as a crude index of renal function in studies of patients with CKD, but it is not reliable. The glomerular filtration rate (GFR) should be used instead. GFR is the most accurate way to give health providers an estimate of functioning renal mass. Estimating GFR with the use of prediction equations is cost effective.
In this study, we will prospectively evaluate the effect of percutaneous nephrolithotomy on the estimated glomerular filtration rate in Patients With Stage 2-4 chronic kidney disease.
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- Percutaneous nephrolithotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrolithotomyProcedure or surgery
Percutaneous nephrolithotomy (PCNL) is a technique used to remove complex renal stones, or stones resistant to shockwave lithotripsy. A tube is placed through the incision in the kidney, under X-ray guidance, and renal stones are extracted by using nephroscope
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | Adult patients with age group ≥ 18 years old with renal stones candidate for PCNL with pre-operative estimated GFR less than 90 ml/min/1.7 m2 and ≥ 15 ml/min/1.7 m2. Receives: Procedure: Percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of GFR for all patients pre-operative
Estimation of GFR for all patients pre-operative by using body surface area based-Cockcroft-Gault formula (CG/ BSA).
Body surface area based Cockcroft-Gault formula (CG/ BSA) = [(140- age) x weight in kilograms x (0.85 if female)] / (72 x serum creatinine in mg/dl).
This formula expects weight to be measured in kilograms and creatinine to be measured in mg/dl.
Measured: 1 day pre-operative
Estimation of GFR for all patients three months post-operative
Estimation of GFR for all patients three months post-operative by using body surface area based-Cockcroft-Gault formula (CG/ BSA).
Body surface area based Cockcroft-Gault formula (CG/ BSA) = [(140- age) x weight in kilograms x (0.85 if female)] / (72 x serum creatinine in mg/dl).
This formula expects weight to be measured in kilograms and creatinine to be measured in mg/dl.
Measured: 3 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Adult patients with age group ≥ 18 years old with renal stones candidate for PCNL with pre-operative estimated GFR less than 90 ml/min/1.7 m2 and ≥ 15 ml/min/1.7 m2.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelghany Allam, Assiut University
- Investigators
- Adel Kurkar, Study director, Assiut UniversityAhmed Moeen, Study director, Assiut UniversityAmr Abo-Faddan, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943081
- Sponsor's protocol ID
- PCNL in chronic kidney disease
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Edvardsson VO, Indridason OS, Haraldsson G, Kjartansson O, Palsson R. Temporal trends in the incidence of kidney stone disease. Kidney Int. 2013 Jan;83(1):146-52. doi: 10.1038/ki.2012.320. Epub 2012 Sep 19.
PubMed 22992468Gupta M, Bolton DM, Gupta PN, Stoller ML. Improved renal function following aggressive treatment of urolithiasis and concurrent mild to moderate renal insufficiency. J Urol. 1994 Oct;152(4):1086-90. doi: 10.1016/s0022-5347(17)32509-0.
PubMed 8072069Jungers P, Joly D, Barbey F, Choukroun G, Daudon M. ESRD caused by nephrolithiasis: prevalence, mechanisms, and prevention. Am J Kidney Dis. 2004 Nov;44(5):799-805.
PubMed 15492945Gambaro G, Favaro S, D'Angelo A. Risk for renal failure in nephrolithiasis. Am J Kidney Dis. 2001 Feb;37(2):233-43. doi: 10.1053/ajkd.2001.21285.
PubMed 11157364National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
PubMed 11904577Gopalakrishnan G, Prasad GS. Management of urolithiasis with chronic renal failure. Curr Opin Urol. 2007 Mar;17(2):132-5. doi: 10.1097/MOU.0b013e328028fdfb.
PubMed 17285024Jones P, Aboumarzouk OM, Rai BP, Somani BK. Percutaneous Nephrolithotomy for Stones in Solitary Kidney: Evidence From a Systematic Review. Urology. 2017 May;103:12-18. doi: 10.1016/j.urology.2016.10.022. Epub 2016 Nov 14.
PubMed 27856206
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Percutaneous Nephrolithotomy on the Estimated Glomerular Filtration Rate in Patients With Stage 2-4 Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04943081
- Acronym / sponsor ID
- PCNL in chronic kidney disease
- Conditions
- Percutaneous Nephrolithotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 29 Jun 2021 (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 study aims to evaluate the effect of percutaneous nephrolithotomy (PCNL) on estimated glomerular filtration rate (eGFR) in patients with stage 2-4 chronic kidney disease
Detailed description
Nephrolithiasis affects an estimated 5-10% of the general population, and this percentage continues to rise. It has a prevalence of 1.7% to 18% in patients with chronic kidney disease (CKD), and nephrolithiasis-related CKD contributed to 3.2% of the total patients who started maintenance dialysis therapy.
The etiology of renal insufficiency in patients with nephrolithiasis is multifactorial and includes renal obstruction, recurrent urinary tract infections, frequent surgical interventions and coexisting medical disease.
According to National kidney foundation, chronic kidney disease is classified into 5 stages as follows:
Stage 1: Kidney damage with normal or elevated GFR < 90 ml/min/1.7 m2 Stage 2: Kidney damage with mildly decreased GFR 60-89 ml/min/1.7 m2 Stage 3: Moderately decreased GFR 30-59 ml/min/1.7 m2 Stage 4: Severely decreased GFR 15-29 ml/min/1.7 m2 Stage 5: Kidney Failure GFR>15 ml/min/1.7 m2 Management of nephrolithiasis in patients with CKD is often difficult. Options for preserving kidney function include watchful waiting, shockwave lithotripsy (SWL), an endourologic approach (Percutaneous nephrolithotomy or retrograde intra-renal surgery), laparoscopic surgery or conventional open surgery.
Percutaneous nephrolithotomy (PCNL) is considered as the gold standard intervention for large burden and complex renal stone disease and is associated with the highest stone free rates (SFRs). However, potentially significant complications include bleeding, sepsis, pleural and visceral injury. Therefore, the optimal management plan needs to be tailored to individual patient.
Serum creatinine level has been used as a crude index of renal function in studies of patients with CKD, but it is not reliable. The glomerular filtration rate (GFR) should be used instead. GFR is the most accurate way to give health providers an estimate of functioning renal mass. Estimating GFR with the use of prediction equations is cost effective.
In this study, we will prospectively evaluate the effect of percutaneous nephrolithotomy on the estimated glomerular filtration rate in Patients With Stage 2-4 chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adult patients with age group ≥ 18 years old with renal stones candidate for PCNL with pre-operative estimated GFR less than 90 ml/min/1.7 m2 and ≥ 15 ml/min/1.7 m2.
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Procedure: Percutaneous nephrolithotomyAdult patients with age group ≥ 18 years old with renal stones candidate for PCNL with pre-operative estimated GFR less than 90 ml/min/1.7 m2 and ≥ 15 ml/min/1.7 m2. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with age group ≥ 18 years old with renal stones candidate for PCNL with pre-operative estimated GFR less than 90 ml/min/1.7 m2 and ≥ 15 ml/min/1.7 m2
Key exclusion criteria (5 listed)
- Patients with chronic renal failure on regular dialysis.
- Patients with bleeding diathesis.
- Patients who are unfit for surgery.
- Pregnancy
- Patients who are refusing the participation in our study.
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 |
|---|---|---|
| Percutaneous nephrolithotomyPercutaneous nephrolithotomy (PCNL) is a technique used to remove complex renal stones, or stones resistant to shockwave lithotripsy. A tube is placed through the incision in the kidney, under X-ray guidance, and renal stones are extracted by using nephroscope | Procedure or surgery | Case group |
Primary outcome
Estimation of GFR for all patients pre-operative
Time frame: 1 day pre-operative
Estimation of GFR for all patients pre-operative by using body surface area based-Cockcroft-Gault formula (CG/ BSA). Body surface area based Cockcroft-Gault formula (CG/ BSA) = [(140- age) x weight in kilograms x (0.85 if female)] / (72 x serum creatinine in mg/dl). This formula expects weight to be measured in kilograms and creatinine to be measured in mg/dl.
Estimation of GFR for all patients three months post-operative
Time frame: 3 months post-operative
Estimation of GFR for all patients three months post-operative by using body surface area based-Cockcroft-Gault formula (CG/ BSA). Body surface area based Cockcroft-Gault formula (CG/ BSA) = [(140- age) x weight in kilograms x (0.85 if female)] / (72 x serum creatinine in mg/dl). This formula expects weight to be measured in kilograms and creatinine to be measured in mg/dl.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Background: PubMed 22992468Edvardsson VO, Indridason OS, Haraldsson G, Kjartansson O, Palsson R. Temporal trends in the incidence of kidney stone disease. Kidney Int. 2013 Jan;83(1):146-52. doi: 10.1038/ki.2012.320. Epub 2012 Sep 19.
- Background: PubMed 8072069Gupta M, Bolton DM, Gupta PN, Stoller ML. Improved renal function following aggressive treatment of urolithiasis and concurrent mild to moderate renal insufficiency. J Urol. 1994 Oct;152(4):1086-90. doi: 10.1016/s0022-5347(17)32509-0.
- Background: PubMed 15492945Jungers P, Joly D, Barbey F, Choukroun G, Daudon M. ESRD caused by nephrolithiasis: prevalence, mechanisms, and prevention. Am J Kidney Dis. 2004 Nov;44(5):799-805.
- Background: PubMed 11157364Gambaro G, Favaro S, D'Angelo A. Risk for renal failure in nephrolithiasis. Am J Kidney Dis. 2001 Feb;37(2):233-43. doi: 10.1053/ajkd.2001.21285.
- Background: PubMed 11904577National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
- Background: PubMed 17285024Gopalakrishnan G, Prasad GS. Management of urolithiasis with chronic renal failure. Curr Opin Urol. 2007 Mar;17(2):132-5. doi: 10.1097/MOU.0b013e328028fdfb.
- Background: PubMed 27856206Jones P, Aboumarzouk OM, Rai BP, Somani BK. Percutaneous Nephrolithotomy for Stones in Solitary Kidney: Evidence From a Systematic Review. Urology. 2017 May;103:12-18. doi: 10.1016/j.urology.2016.10.022. Epub 2016 Nov 14.
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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.
Adel Kurkar study director
Assiut University
Ahmed Moeen study director
Assiut University
Amr Abo-Faddan study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous nephrolithotomy in people with Percutaneous Nephrolithotomy, run by Assiut University.
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 1 inclusion and 5 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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed Abdelghany (+201021474046, m.abdelghany746@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of GFR for all patients pre-operative (time frame: 1 day pre-operative). 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 NCT04943081, which also lists 7 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 29 Jun 2021.