Comparing two methods for treating medium-sized kidney stones
Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones: a Multicenter Prospective Randomized Controlled Trial
NA · The First Hospital of Jilin University · NCT06507176
This study is testing whether a less invasive method for treating medium-sized kidney stones works just as well as a more traditional approach for people with stones that are 2-4 cm in size.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University (other) |
| Locations | 1 site (Ch'ang-ch'un, Jilin) |
| Trial ID | NCT06507176 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of flexible ureteroscopic lithotripsy versus percutaneous nephrolithotomy for treating kidney stones measuring 2-4 cm. It aims to determine if the less invasive ureteroscopic method can achieve results comparable to the more traditional percutaneous approach. The study involves a prospective randomized controlled design, allowing for a direct comparison of outcomes between the two treatment modalities. By providing evidence-based insights, the trial seeks to enhance treatment options for both physicians and patients dealing with urolithiasis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a diagnosis of kidney stones between 2-4 cm in size and an ASA score of 1-2.
Not a fit: Patients with severe urinary tract infections, significant obesity, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer patients a less invasive treatment option for kidney stones with similar efficacy to traditional methods.
How similar studies have performed: Previous studies have shown promising results for both flexible ureteroscopy and percutaneous nephrolithotomy, indicating that this comparative approach is relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patient agrees to participate in the experiment and signs the informed consent, including compliance with the requirements of the experiment 2. American Society of Anesthesiologists (ASA) score of 1-2, tolerate surgery 3. Age 18-70 years old 4. Diagnosed with renal stones via CT scan, with the largest diameter of the stone being 2-4 cm. Exclusion Criteria: 1. Excessive obesity, BMI \> 28 2. Severe urinary tract infection not corrected 3. Previous history of kidney transplantation or urinary tract diversion surgery 4. Uncorrected bleeding or patients with coagulation dysfunction 5. Urinary system congenital malformations, such as polycystic kidney, horseshoe kidney, pelvic ectopic kidney, etc 6. Combined with serious heart and lung dysfunction and failure of important organs and cannot tolerate anesthesia or surgery
Where this trial is running
Ch'ang-ch'un, Jilin
- Yanbowang — Ch'ang-ch'un, Jilin, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Stone, kidney stone, flexible ureteroscope, percutaneous nephroscopic surgery