- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07685587
COMPARISON OF FANS VS CONVENTIONAL URETERAL ACCESS SHEATH in RIRS on POSTOPERATIVE ACUTE KIDNEY INJURY (FANS)
Comparison of the Effects of Flexible and Navigable Suction With Conventional Ureteral Access Sheaths During Retrograde Intrarenal Surgery on Postoperative Acute Renal Injury With IL-18 and L-FABP Biomarkers: A Prospective Randomised Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Urinary system stone disease is a common condition in urological practice, and with advances in minimally invasive surgical techniques, retrograde intrarenal surgery (RIRS) has become a widely preferred method, particularly for treating small and medium-sized kidney stones, owing to its high stone-free rates and low morbidity. The ureteral access sheath (UAS), routinely used during RIRS, offers advantages such as facilitating repeated entry and exit, shortening operation time, optimizing irrigation flow, and reducing intrarenal pressure. However, controlling intrarenal pressure is critical not only for surgical comfort but also for renal physiology and patient safety. Increased intrarenal pressure can lead to pyelovenous, pyelolymphatic, and pyelotubular regurgitation, increasing the risk of bacterial translocation, sepsis, and renal parenchymal damage. In particular, the damage that high intrarenal pressure can cause to the renal parenchyma and the resulting acute kidney injury (AKI) are of significant importance in critically ill patients who are clinically at risk of renal failure. Recent developments of aspiration-enabled intrarenal electroconvulsive (IOC) systems aim to more effectively and continuously control intrarenal pressure by providing active fluid drainage. Theoretical advantages of these systems include lower intrarenal pressure levels, improved visualization quality, and potentially lower complication rates. However, the effects of these systems on renal function have been evaluated in a limited number of studies in the current literature, and their effects, particularly on subclinical renal damage, have not been clearly established.
Acute renal injury (AKI) is a rare but clinically significant complication following RIRS, and it is often undetectable early using conventional biochemical parameters (e.g., serum creatinine). Therefore, the use of early and sensitive biomarkers is becoming increasingly important. In this context, Interleukin-18 and Liver-type fatty acid binding protein (L-FABP) stand out as promising biomarkers that can reflect early renal tubular damage and predict the development of AKI. The aim of this study is to comparatively evaluate the effects of aspiration and non-aspiration ureteral access sheath systems used during RIRS on postoperative acute renal injury, based on changes in IL-18 and L-FABP levels. Furthermore, by revealing the relationship between intrarenal pressure control and biochemical injury markers, the study aims to provide stronger evidence for the potential clinical benefits of aspiration systems.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: mehmet fatih M. şahin, associate professor
- Telefonnummer: +90 555 551 1871
- E-mail: mfatihsahin@gmail.com
Studiesteder
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Tekirdağ, Tyrkiet (Türkiye)
- Rekruttering
- Tekirdag Namık Kemal University
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Kontakt:
- Mehmet F. Şahin, associate professor
- Telefonnummer: +90 555 551 1871
- E-mail: mfatihsahin@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Being 18 years of age or older
- Having a planned RIRS operation
- Providing written informed consent
Exclusion Criteria:
- Patients who do not give consent
- Patients who will undergo combined surgery
- Patients who have previously undergone endoscopic stone surgery
- Being under 18 years of age
- Patients with chronic kidney failure
- Patients with kidney malformations
- Patients with a solitary kidney
- Patients using nephrotoxic drugs
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Patients operated with FANS-UAS
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Patients of RIRS operated with flexible and navigable ureteral access sheath
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Aktiv komparator: Patients operated with conventional-UAS
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Patients of RIRS operated with conventional ureteral access sheath
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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acute kidney injury
Tidsramme: preoperative, postoperative 24th hour and postoperative 7. days
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Serum IL-18 and L-FABP levels at the stated timelines.
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preoperative, postoperative 24th hour and postoperative 7. days
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Traxer O, Thomas A. Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. J Urol. 2013 Feb;189(2):580-4. doi: 10.1016/j.juro.2012.08.197. Epub 2012 Oct 8.
- Ecer G, Sonmez MG, Guven S, Balasar M. RE: Wang, D. (2023). Re: comparison of retrograde intrarenal stone surgery with and without a ureteral access sheath using kidney injury molecule-1 (KIM-1) levels: a prospective randomized study by Gokhan Ecer, Mehmet Giray Sonmez, Arif Aydin, Cemile Topcu, Haider Nihad Izaddin Alalam, Selcuk Guven, and Mehmet Balasar. Urolithiasis, 51(1), 44. Urolithiasis. 2023 May 3;51(1):81. doi: 10.1007/s00240-023-01450-6. No abstract available.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026.170.05.32
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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