COMPARISON OF FANS VS CONVENTIONAL URETERAL ACCESS SHEATH in RIRS on POSTOPERATIVE ACUTE KIDNEY INJURY (FANS)

July 1, 2026 updated by: Mehmet Fatih Şahin, Namik Kemal University

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

Kidney stone disease is a common condition, and retrograde intrarenal surgery (RIRS) is a minimally invasive procedure frequently used to remove kidney stones. During RIRS, pressure inside the kidney can increase, which may contribute to temporary kidney injury. New aspiration-enabled access sheath systems have been developed to better control this pressure by continuously removing irrigation fluid during surgery. This study will compare aspiration and conventional access sheath systems to determine whether improved pressure control reduces early kidney injury. Blood and urine biomarkers (IL-18 and L-FABP), which can detect kidney damage earlier than standard kidney function tests, will be measured before and after surgery. The results may help identify surgical techniques that better protect kidney function and improve the safety of kidney stone treatment for patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: mehmet fatih M. şahin, associate professor
  • Phone Number: +90 555 551 1871
  • Email: mfatihsahin@gmail.com

Study Locations

  • Turkey (Türkiye)
      • Tekirdağ, Turkey (Türkiye)
        • Recruiting
        • Tekirdag Namık Kemal University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients operated with FANS-UAS
Device: flexible and navigable ureteral access sheath
Patients of RIRS operated with flexible and navigable ureteral access sheath
Active Comparator: Patients operated with conventional-UAS
Device: conventional ureteral access sheath
Patients of RIRS operated with conventional ureteral access sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute kidney injury
Time Frame: preoperative, postoperative 24th hour and postoperative 7. days
Serum IL-18 and L-FABP levels at the stated timelines.
preoperative, postoperative 24th hour and postoperative 7. days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namik Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

June 27, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026.170.05.32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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