A Prospective Multicenter Randomized Controlled Trial of Flexible And Navigable Suction Ureteral Access Sheath Combined With Needle Perc for the Treatment of Partial Staghorn Renal Calculi

Launched by BEIJING TSINGHUA CHANG GUNG HOSPITAL · Apr 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat a type of kidney stone called partial staghorn renal calculi. The researchers want to find out if a special device, known as a flexible and navigable suction ureteral access sheath combined with needle perc, works as well as a more traditional method called PCNL (Percutaneous Nephrolithotomy) in getting rid of these stones. They are also looking at the safety of a drug referred to as ABC. Participants will undergo one of the two treatments and will have follow-up visits at the clinic one month and three months after their surgery to check on their recovery and the success of the treatment.

To be eligible for this trial, participants should be between 18 and 80 years old and have a CT scan showing they have partial staghorn calculi. They also need to be able to follow the study guidelines and sign an informed consent form. However, those with severe kidney problems, certain types of kidney stones or conditions, or a history of major kidney surgery may not be able to participate. This trial is not yet recruiting participants, but it aims to help improve treatment options for kidney stones in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18-80 years
• • 2. CT scan indicates partial staghorn calculi
• • 3. Able to complete the study in accordance with the protocol requirements
• • 4. Informed about the study and has signed the informed consent form
• Exclusion Criteria:
• • 1. Severe renal insufficiency (GFR \< 30 ml/min/1.73 m²)
• • 2. Significant calyceal hydronephrosis (calyceal width ≥ 2 cm)
• • 3. Renal stone volume \> 33.5 cm³
• • 4. Renal stones or nephrocalcinosis caused by genetic diseases or definite metabolic disorders that have not been ruled out, such as renal tubular acidosis, primary hyperoxaluria, primary hyperparathyroidism, etc.
• • 5. Congenital or structural renal abnormalities: spinal deformity, ankylosing spondylitis, horseshoe kidney, medullary sponge kidney, duplicated kidney, polycystic kidney, ectopic kidney, etc.
• • 6. History of previous open renal stone surgery
• • 7. Patients with uncontrolled urinary tract infections
• • 8. Subjects deemed by the investigator to have other factors that make them unsuitable for participation in this trial