Percutaneous Nephrolithotomy in Patients With Stage 2-4 Chronic Kidney Disease
Primary Purpose
Percutaneous Nephrolithotomy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous nephrolithotomy
Sponsored by
About this trial
This is an interventional treatment trial for Percutaneous Nephrolithotomy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Case group
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04943081
Brief Title
Percutaneous Nephrolithotomy in Patients With Stage 2-4 Chronic Kidney Disease
Official Title
The Effect of Percutaneous Nephrolithotomy on the Estimated Glomerular Filtration Rate in Patients With Stage 2-4 Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Nephrolithotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Case group
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous nephrolithotomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Estimation of GFR for all patients pre-operative
Description
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.
Time Frame
1 day pre-operative
Title
Estimation of GFR for all patients three months post-operative
Description
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.
Time Frame
3 months post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abdelghany
Phone
+201021474046
Email
m.abdelghany746@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adel Kurkar
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Moeen
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amr Abo-Faddan
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
22992468
Citation
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. Erratum In: Kidney Int. 2013 May;83(5):972.
Results Reference
background
PubMed Identifier
8072069
Citation
Gupta 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.
Results Reference
background
PubMed Identifier
15492945
Citation
Jungers 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.
Results Reference
background
PubMed Identifier
11157364
Citation
Gambaro 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.
Results Reference
background
PubMed Identifier
11904577
Citation
National 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.
Results Reference
background
PubMed Identifier
17285024
Citation
Gopalakrishnan G, Prasad GS. Management of urolithiasis with chronic renal failure. Curr Opin Urol. 2007 Mar;17(2):132-5. doi: 10.1097/MOU.0b013e328028fdfb.
Results Reference
background
PubMed Identifier
27856206
Citation
Jones 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.
Results Reference
background
Learn more about this trial
Percutaneous Nephrolithotomy in Patients With Stage 2-4 Chronic Kidney Disease
We'll reach out to this number within 24 hrs