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

NCT ID: NCT06914986

Last Updated: 2025-04-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 344 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2028-03-01

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

Conditions

Urinary Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

flexible and navigable suction ureteral access sheath combined with needle perc

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Patients are performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL

PCNL group

Group Type: OTHER

PCNL

Intervention Type: PROCEDURE

Patients were performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL

Interventions

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

Patients are performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL

Intervention Type: PROCEDURE

PCNL

Patients were performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

bo xiao, M.D.

Role: CONTACT

beidaxiaobo@163.com

86+13811403056

Other Identifiers

24747-0-02

Identifier Type: -

Identifier Source: org_study_id