N/A
N=108
Trial Assessing Renal Damage During Ureteroscopy
Nephrolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT05350423 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change in Kidney Injury Molecule-1 (KIM-1) — 0.01077; 0.01228; 0.0246; 0.02413 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Thulium Fibre Laser (Device); Holmium:Yttrium-Aluminum-Garnet (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Kidney Injury Molecule-1 (KIM-1) |
0.01077; 0.01228; 0.0246; 0.02413; 0.0161; 0.0188 | — |
| PRIMARY Change in Neutrophil Gelatinase-associated Lipocalin (NGAL) |
0.5263; 0.5723; 2.5181; 2.4486; 1.8233; 2.4499 | — |
| PRIMARY Change in β2-microglobulin (β2M) |
2.1262; 2.7747; 25.6231; 17.1472; 12.5832; 4.4599 | — |
| SECONDARY Operative Time |
52.5; 56.0 | — |
Summary
This is an ongoing randomized controlled trial of patients undergoing URSLL with unilateral non-obstructing renal stones. Patients are randomized to undergo URSLL with either the TFL or Ho:YAG laser. Each patient's urine is collected immediately pre-op (V1), 1 hour post-op (V2), and 10 days post-op (POD#10, V3). Samples are analyzed by enzyme-linked immunosorbent assay (ELISA) for the following biomarkers: Kidney injury molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), and β2-microglobulin (β2M), then normalized to urine creatinine.
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 18 years
- Patients undergoing unilateral ureteroscopic laser lithotripsy for the treatment of non-obstructing renal stones
- Total stone burden between 5 and 20 mm
Exclusion Criteria
- Presence of pre-existing indwelling ureteral stent
- Presence of hydronephrosis preoperatively (on either side)
- CKD as defined by eGFR < 60 mL/min
- GU anatomical anomalies (including urinary diversion, solitary kidney, ureteral stricture disease, ureteropelvic junction obstruction)
Data sourced from ClinicalTrials.gov (NCT05350423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.