The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury

NCT03112499 | Completed

• 1 other identifier: 1343/2017
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of the study is to investigate and compare the possible acute effect of standard PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy (stone-free rate), safety (complication rate, long-term kidney function) and other parameters (operation, fluoroscopy and hospitalization time) concerning the 3 endourological operations (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.

Conditions

Renal Calculi; Renal Insufficiency

Keywords

Acute Kidney Injury; PCNL; mini-PCNL; RIRS; urine biomarkers

Outcome Measures

Primary Outcomes (1)

• The change in urine NGAL/Cr value

  Urine NGAL/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique.

  2 hours preoperative and 2 hours postoperatively

Secondary Outcomes (14)

• The change in urine NGAL/Cr value

  2 hours preoperative and 6, 24, 48 hours postoperatively

• The change in urine KIM-1/Cr value

  2 hours preoperative and 2, 6, 24, 48 hours postoperatively

• The change in urine IL-18/Cr value

  2 hours preoperative and 2, 6, 24, 48 hours postoperatively

• The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with standard PCNL and those undergone nephrolithotripsy with mini - PCNL technique

  2, 6, 24, 48 hours postoperatively

• The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with standard PCNL and those undergone nephrolithotripsy with RIRS technique

  2, 6, 24, 48 hours postoperatively

Study Arms (3)

PCNL Group

ACTIVE COMPARATOR

Patients with renal calculi 10-30mm in maximal diameter in who percutaneous nephrolithotomy (PCNL) will be conducted

Procedure: PCNL

mini-PCNL Group

ACTIVE COMPARATOR

Patients with renal calculi 10-30mm in maximal diameter in who mini- percutaneous nephrolithotomy (mini-PCNL) will be conducted

Procedure: mini-PCNL

RIRS Group

ACTIVE COMPARATOR

Patients with renal calculi 10-30mm in maximal diameter in who retrograde intrarenal surgery (RIRS) will be conducted

Procedure: RIRS

Interventions

PCNL PROCEDURE

Under general anesthesia and patient in prone position, with the use of a flexible cystoscope an open-ended ureteral catheter 5F / 70cm is positioned to the proximal ureter. Retrograde pyelography is performed and the most appropriate calyx is accessed with the use of ultrasound, under fluoroscopic guidance. A 0.035 guide wire is inserted into the ureter and then replaced with an extra stiff wire. Using either balloon (20 atm) or Amplatz serial dilators a 30F access channel is created. Lithotripsy is performed using ultrasound lithotripter and stone fragments are removed by grasping forceps. At the end of the operation a 18F Council type catheter is placed into the kidney for drainage of urine and an indwelling JJ catheter is inserted in the ipsilateral ureter. Council and JJ catheter are removed,in the absence of complications, the second and tenth postoperative day, respectively.

PCNL Group

mini-PCNL PROCEDURE

Under general anesthesia and patient in prone position, with the use of a flexible cystoscope an open-ended ureteral catheter 5F / 70cm is positioned to the proximal ureter. Retrograde pyelography is performed and the most appropriate calyx is accessed with the use of ultrasound, under fluoroscopic guidance. A 0.035 guide wire is inserted into the ureter and then replaced with an extra stiff wire. Using Amplatz serial dilators a 16F access channel is created. Lithotripsy is performed using using 270mm Ho: YAG laser fiber and stone fragments are removed by grasping forceps. At the end of the operation a 10F nephrostomy tube is placed into the kidney for drainage of urine and an indwelling JJ catheter is inserted in the ipsilateral ureter. Nephrostomy tube and JJ catheter are removed, in the absence of complications, the second and tenth postoperative day, respectively.

mini-PCNL Group

RIRS PROCEDURE

Under general anesthesia and patient in lithotomy position, a 0.035 hydrophilic safety wire is inserted in the ureter under fluoroscopic guidance. Subsequently 8-10 F dilators are used for dilation of the ureter.Insertion of a second working wire follows above which a 14F ureteral sheath is placed. Lithotripsy with a flexible ureteroscope using 270mm Ho: YAG laser fiber follows.Remaining stone fragments are removed by a 2,2F nitinol basket. At the end of the operation a JJ indwelling ureteral catheter is placed over the safety wire. Discharge is performed in the absence of complications, the first postoperative day while JJ catheter is removed on the 10th postoperative day.

RIRS Group

Eligibility Criteria

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

You may qualify if:

• Patients aged \> 18 years old
• Patients with renal stone or stones of 10-30 mm in maximal diameter measured in computed tomography scan.
• Decision of the patient to receive surgical treatment
• Ability to understand and provide a written informed consent to participate in the study.

You may not qualify if:

• Solitary kidney (functional or organic)
• Ureteral stone in the same system causing obstruction
• Malignant tumor in the treated kidney
• Stone in diverticulum
• Diabetes or coronary heart disease.
• History of surgery in the treated kidney
• Recent intake of drugs that affect renal function or intravenous contrast agent
• Concomitant urinary infection
• Congenital anomalies of the urinary tract
• Patients of whom incomplete clinical data or incomplete samples are available

Sponsors & Collaborators

• Institute for the Study of Urological Diseases, Greece: lead

Study Sites (1)

G.Gennimatas Hospital

Thessaloniki, 54621, Greece

Location

Related Publications (8)

• Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

  PMID: 22890468 BACKGROUND

• Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A; NGAL Meta-analysis Investigator Group. Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Dec;54(6):1012-24. doi: 10.1053/j.ajkd.2009.07.020. Epub 2009 Oct 21.

  PMID: 19850388 BACKGROUND

• Vaidya VS, Waikar SS, Ferguson MA, Collings FB, Sunderland K, Gioules C, Bradwin G, Matsouaka R, Betensky RA, Curhan GC, Bonventre JV. Urinary biomarkers for sensitive and specific detection of acute kidney injury in humans. Clin Transl Sci. 2008 Dec;1(3):200-8. doi: 10.1111/j.1752-8062.2008.00053.x.

  PMID: 19212447 BACKGROUND

• Lin X, Yuan J, Zhao Y, Zha Y. Urine interleukin-18 in prediction of acute kidney injury: a systemic review and meta-analysis. J Nephrol. 2015 Feb;28(1):7-16. doi: 10.1007/s40620-014-0113-9. Epub 2014 Jun 5.

  PMID: 24899123 BACKGROUND

• Dede O, Dagguli M, Utangac M, Yuksel H, Bodakci MN, Hatipoglu NK, Sancaktutar AA, Penbegul N. Urinary expression of acute kidney injury biomarkers in patients after RIRS: it is a prospective, controlled study. Int J Clin Exp Med. 2015 May 15;8(5):8147-52. eCollection 2015.

  PMID: 26221383 BACKGROUND

• Daggulli M, Utangac MM, Dede O, Bodakci MN, Hatipoglu NK, Penbegul N, Sancaktutar AA, Bozkurt Y, Soylemez H. Potential biomarkers for the early detection of acute kidney injury after percutaneous nephrolithotripsy. Ren Fail. 2016;38(1):151-6. doi: 10.3109/0886022X.2015.1073494. Epub 2015 Oct 19.

  PMID: 26481764 BACKGROUND

• Balasar M, Piskin MM, Topcu C, Demir LS, Gurbilek M, Kandemir A, Ozturk A. Urinary kidney injury molecule-1 levels in renal stone patients. World J Urol. 2016 Sep;34(9):1311-6. doi: 10.1007/s00345-016-1765-y. Epub 2016 Jan 21.

  PMID: 26795762 BACKGROUND

• Soderberg L, Ergun O, Ding M, Parker R, Borofsky MS, Pais V, Dahm P. Percutaneous nephrolithotomy versus retrograde intrarenal surgery for treatment of renal stones in adults. Cochrane Database Syst Rev. 2023 Nov 13;11(11):CD013445. doi: 10.1002/14651858.CD013445.pub2.

  PMID: 37955353 DERIVED

MeSH Terms

Conditions

Kidney Calculi; Renal Insufficiency; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dimitrios Hatzichristou, Prof.

  Institute for the Study of Urological Diseases (ISUD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 13, 2017
• Study Start: June 5, 2018
• Primary Completion: March 15, 2021
• Study Completion: June 15, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)