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NCT Number: NCT07615452

Evaluation of Renal Injury After RIRS Using Shear-Wave Elastography

This study aims to evaluate changes in renal parenchyma following retrograde intrarenal surgery (RIRS) using shear-wave elastography. Renal elastography measurements will be performed in patients undergoing RIRS for kidney stones on the preoperative day, on the first postoperative day, and on the seventh postoperative day. Postoperative pain scores, perioperative outcomes, stone-free status and complications will also be assessed.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Patients undergoing RIRS for renal stones
  • Stone size between < 20 mm
  • Negative urine culture

Exclusion criteria

  • Active urinary tract infection
  • Congenital renal anomalies
  • Solitary kidney
  • Chronic kidney disease
  • Previous PCNL or open surgery
  • Ureteral stricture disease

Treatment and study plan

Aspiration-assisted ureteral access sheath

Device

Patients undergoing retrograde intrarenal surgery using an aspiration-assisted ureteral access sheath

Standard ureteral access sheath

Device

Standard ureteral access sheath used during retrograde intrarenal surgery.

Primary outcomes

  1. Renal Cortical Shear-Wave Elastography Values (kPa)

    Time frame: Elastography assessments will be performed preoperatively, on postoperative day 1, and on postoperative day 7 to evaluate perioperative renal parenchymal changes.

    Renal cortical stiffness will be quantitatively evaluated using ultrasound-based shear-wave elastography. Measurements will be obtained from multiple regions of the renal cortex, and the mean value of these measurements will be recorded in kilopascals (kPa). All examinations will be performed using the same ultrasound device and standardized protocol by a single experienced radiologist blinded to the study groups.

Secondary outcomes

  1. Postoperative Complications

    Time frame: From surgery to postoperative day 30

    Perioperative and postoperative complications assessed according to the Clavien-Dindo classification system.

  2. Serum Creatinine Level

    Time frame: Preoperative baseline, postoperative day 1, and postoperative day 7

    Serum creatinine levels measured to evaluate renal function changes following retrograde intrarenal surgery.

  3. Postoperative Fever and Sepsis

    Time frame: From surgery to postoperative day 30

    Occurrence of postoperative fever (>38°C) and/or sepsis following surgery.

  4. Stone-Free Rate

    Time frame: Postoperative month 1

    Stone-free status assessed by postoperative imaging.

  5. Renal Resistive Index

    Time frame: Preoperative baseline, postoperative day 1 and postoperative day 7

    Renal resistive index values measured using Doppler ultrasonography to evaluate renal vascular resistance following retrograde intrarenal surgery.

  6. Mayo Adhesive Probability Score

    Time frame: Preoperative period

    Perinephric fat adhesion severity assessed using the Mayo Adhesive Probability (MAP) Score based on preoperative computed tomography findings. The MAP Score ranges from 0 to 5, with higher scores indicating a greater likelihood of adherent perinephric fat and increased surgical complexity.

  7. Postoperative Pain Scores

    Time frame: preoperative, postoperative 6th hour, and postoperative 24th hour.

    . Postoperative pain intensity was assessed using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the most severe pain imaginable. Higher scores indicate greater pain intensity.

Study contacts

Contact information is provided by the study sponsor or research team.

Cengiz Çanakcı

CONTACT

[email protected]

+905454738043

Sponsors and collaborators

Lead sponsor

Cengiz Canakci, MD

Other

Registry information

Official study title

Assessment of Renal Parenchymal Damage Following Retrograde Intrarenal Surgery Using Shear-Wave Elastography

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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