Clinical trial NCT06914986: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Calculi
Keywords: partial staghorn renal calculi
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2025-04-07
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Prospective Multicenter Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi. It will also learn about the safety of drug ABC. The main questions it aims to answer are:

* Does flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL
* Does flexible and navigable suction ureteral access sheath combined with needle perc result in more complications compared with PCNL Researchers will compare flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL to see if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi.

Participants will:

* Performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL
* Visit the clinic after surgery 1 month and 3 month for checkups and tests


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

Primary outcomes:
measure: stone free rate
timeFrame: 3 month after surgery
Secondary outcomes:
measure: complications
timeFrame: 3 month after surgery
Other outcomes:
Locations:
Study officials:
References: