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

NCT04943081 | Unknown

• 1 other identifier: PCNL in chronic kidney disease
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Percutaneous Nephrolithotomy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 months post-operative

Study Arms (1)

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.

Procedure: Percutaneous nephrolithotomy

Interventions

Percutaneous nephrolithotomy PROCEDURE

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

Case group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 22992468 BACKGROUND

• 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.

  PMID: 8072069 BACKGROUND

• 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.

  PMID: 15492945 BACKGROUND

• 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.

  PMID: 11157364 BACKGROUND

• 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.

  PMID: 11904577 BACKGROUND

• 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.

  PMID: 17285024 BACKGROUND

• 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.

  PMID: 27856206 BACKGROUND

MeSH Terms

Interventions

Nephrolithotomy, Percutaneous

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Adel Kurkar

  Assiut University

  STUDY DIRECTOR

• Ahmed Moeen

  Assiut University

  STUDY DIRECTOR

• Amr Abo-Faddan

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Abdelghany

CONTACT

+201021474046; m.abdelghany746@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 29, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06