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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04943081
Collaborator
(none)
50
1
15

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous nephrolithotomy
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
The Effect of Percutaneous Nephrolithotomy on the Estimated Glomerular Filtration Rate in Patients With Stage 2-4 Chronic Kidney Disease
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Case group

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.

Procedure: Percutaneous nephrolithotomy
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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Adel Kurkar, Assiut University
  • Study Director: Ahmed Moeen, Assiut University
  • Study Director: Amr Abo-Faddan, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Abdelghany Allam, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT04943081
Other Study ID Numbers:
  • PCNL in chronic kidney disease
First Posted:
Jun 29, 2021
Last Update Posted:
Jun 29, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2021