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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tsinghua Chang Gung Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Aged 18-80 years

CT scan indicates partial staghorn calculi

Able to complete the study in accordance with the protocol requirements

Informed about the study and has signed the informed consent form

Disqualifiers

Severe renal insufficiency (GFR < 30 ml/min/1.73 m²)

Significant calyceal hydronephrosis (calyceal width ≥ 2 cm)

Renal stone volume > 33.5 cm³

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

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

  • PCNL

    Procedure/Surgery

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

Treatment groups

344 Participants
are divided into 2 treatment groups
Group A: flexible and navigable suction ureteral access sheath combined with needle percExperimental treatment 1 intervention
Group B: PCNL groupOther 1 intervention

Trial outcomes

Primary outcomes

1

stone free rate

Patient will have CT scan 3 month after surgery

Time frame
3 month after surgery

Secondary outcomes

1

complications

Patients were recorded complications after surgery

Time frame
3 month after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: