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

NCT06750913 | Completed DMC

• 1 other identifier: Guohua Zeng
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• the first access time

  1 week

• Duration of surgery

  Intraoperative

Secondary Outcomes (2)

• Stone clearance rate

  1 week

• Complications of surgery

  1 week

Study Arms (2)

Experimental group

EXPERIMENTAL

In the study group, the patient is directly placed in the split-leg prone position. A 10-cm soft pillow is used to elevate the upper abdomen, making the lower edge of the pubic symphysis exceed the lower edge of the operating table by 5 cm. The patient's legs are spread in a V-shaped manner. The thigh on the healthy side is abducted as much as possible, while the thigh on the affected side is slightly abducted, so that the angle between the two legs is approximately 80°. The lumbar back and perineum are disinfected and covered with sterile drapes, and an indwelling urinary catheter is inserted for open drainage. The target renal calyx is punctured percutaneously under the guidance of ultrasound, and an 18 - 24 Fr tract is established under the guidance of a guidewire. A peel-away working sheath is then left in place, completing the establishment of the tract.

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

Control group

NO INTERVENTION

In the control group, the patient is first placed in the lithotomy position. A 5 Fr ureteral catheter is retrogradely inserted into the ureter on the affected side via a cystoscope, along with a 16 Fr Foley catheter. Then, the patient is turned to the prone position, and a 10-cm soft pillow is used to elevate the upper abdomen. The surgical area is disinfected and draped again. Sterile normal saline is injected through the ureteral catheter to create artificial hydronephrosis. The target renal calyx is punctured percutaneously under the guidance of ultrasound, and retrograde contrast is performed when necessary, combined with X-ray-guided percutaneous puncture. Subsequently, an 18 - 24 Fr tract is established under the guidance of a guidewire, and a peel-away working sheath is left in place, thus completing the establishment of the tract.

Interventions

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

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Urinary Calculi

Interventions

Catheterization

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: February 7, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 16, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (1)