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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Percutaneous Nephrolithotomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 18, 2021
    Last Updated
    June 25, 2021
    Sponsor
    Assiut University
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    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

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

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