Evaluation of Renal Injury After RIRS Using Shear-Wave Elastography

NCT07615452 | Not Yet Recruiting

• 1 other identifier: canakci 003
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Kidney Stone

Keywords

Retrograde intrarenal surgery; Shear-wave elastography; Kidney injury; kidney stone

Outcome Measures

Primary Outcomes (1)

• Renal Cortical Shear-Wave Elastography Values (kPa)

  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.

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

Secondary Outcomes (7)

• Postoperative Complications

  From surgery to postoperative day 30

• Serum Creatinine Level

  Preoperative baseline, postoperative day 1, and postoperative day 7

• Postoperative Fever and Sepsis

  From surgery to postoperative day 30

• Stone-Free Rate

  Postoperative month 1

• Renal Resistive Index

  Preoperative baseline, postoperative day 1 and postoperative day 7

Study Arms (2)

Aspiration-assisted ureteral access sheath

EXPERIMENTAL

Patients will undergo retrograde intrarenal surgery using an aspiration-assisted ureteral access sheath.

Device: Aspiration-assisted ureteral access sheath

Standard ureteral access sheath

ACTIVE COMPARATOR

Patients will undergo retrograde intrarenal surgery using a standard ureteral access sheath.

Device: Standard ureteral access sheath

Interventions

Aspiration-assisted ureteral access sheath DEVICE

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

Aspiration-assisted ureteral access sheath

Standard ureteral access sheath DEVICE

Standard ureteral access sheath used during retrograde intrarenal surgery.

Standard ureteral access sheath

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cengiz Canakci, MD: lead

MeSH Terms

Conditions

Kidney Calculi

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

Central Study Contacts

Cengiz Çanakcı

CONTACT

+905454738043; cengizcanakci@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assos. Prof.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share