Retrograde Ureteral Catheterization Is Not Essential in Percutaneous Nephrolithotomy: A Randomized Controlled Trial

Summary

Percutaneous nephrolithotomy (PCNL) is currently the first-line treatment for upper urinary tract stones larger than 2 cm. It is minimally invasive and enables rapid recovery, thus winning the approval of patients . In the traditional PCNL procedure, a ureteral catheter is first retrogradely inserted into the ureter on the affected side with the patient in the lithotomy position, and then the patient is changed to the prone position for percutaneous renal puncture and stone extraction . The inserted catheter can be used for retrograde injection of water or contrast agents, which facilitates percutaneous renal puncture and also prevents stone fragments from entering the ureter during the lithotripsy process . However, under the lithotomy position, disinfection, draping, and intubation are carried out first, and then the patient is turned to the prone position for another round of disinfection and draping, which is cumbersome and requires a long surgical preparation time.

In recent years, with the enrichment of urologists' experience in percutaneous renal puncture and the improvement of the quality of ultrasound images, the application of percutaneous renal puncture and fistulization guided by ultrasound has become more and more widespread . Experienced urologists can even puncture the target renal calyx without the need for retrograde intubation and injection of water to form an "artificial hydronephrosis". Combined with intraoperative contrast verification through the puncture needle, accurate puncture can be ensured. This saves the surgical time required for the traditional PCNL, which involves retrograde intubation in the lithotomy position followed by a change to the prone position, and also avoids the risk of infection that may be increased due to elevated renal pelvic pressure during retrograde injection. However, failure to place a retrograde catheter during PCNL may increase the difficulty of puncture and the risk of stone fragments entering the ureter during the lithotripsy process. We adopt the split-leg prone position, and when necessary, retrograde ureteroscopic operations can be performed. In this way, various needs for anterograde and retrograde operations can be met in a single position .

Direct percutaneous renal puncture and stone extraction under the guidance of ultrasound combined with X-ray without retrograde intubation in the split-leg prone position has both advantages and disadvantages, posing a challenge to surgeons. To verify the safety and feasibility of this technique, we have launched this clinical randomized controlled trial for verification.

Conditions

• Urinary Stones

Interventions

PROCEDURE

Comparison between PCNL without Catheterization in the Split-leg Prone Position and Traditional PCNL

Before the start of PCNL, one group of patients was placed in the lithotomy position and then converted to the prone position, and one group of patients directly separated from the leg prone position without an external brace

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-07

Primary Completion

2026-02-15

Completion

2026-02-16

Countries

• China

Study Locations