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

Not Applicable

Not yet recruiting

• Conditions: Urinary Calculi

• Registration Number: NCT06914986
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-04-01
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-07
• Last Update Posted: 2025-04-07
• Primary Completion: 2027-12-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 344

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
stone free rate	3 month after surgery	Patient will have CT scan 3 month after surgery

Secondary Outcome Measures

Name	Time	Method
complications	3 month after surgery	Patients were recorded complications after surgery