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

Beijing Tsinghua Chang Gung Hospital

Status: Not yet enrolling

Conditions: Urinary Calculi

Treatments: Procedure: PCNL; Procedure: Performed flexible and navigable suction ureteral access sheath combined with needle perc

Study type: Interventional

Funder types: Other

Identifiers

NCT06914986

24747-0-02

Details and patient eligibility

About

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

Enrollment: 344 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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344 participants in 2 patient groups

flexible and navigable suction ureteral access sheath combined with needle perc

Experimental group

Treatment:

Procedure: Performed flexible and navigable suction ureteral access sheath combined with needle perc

PCNL group

Other group

Treatment:

Procedure: PCNL