Percutaneous Nephrolithotomy in Patients With Stage 2-4 Chronic Kidney Disease

Not Applicable

• Conditions: Percutaneous Nephrolithotomy
• Interventions: Procedure: Percutaneous nephrolithotomy

• Registration Number: NCT04943081
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-25
• Last Update Submitted: 2021-06-25
• Study First Posted: 2021-06-29
• Last Update Posted: 2021-06-29
• Study Start: 2021-07-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Case group	Percutaneous nephrolithotomy	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.

Primary Outcome Measures

Name	Time	Method
Estimation of GFR for all patients three months post-operative	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.
Estimation of GFR for all patients pre-operative	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.