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Early vs Delayed Extracorporeal Shock Wave Lithotripsy for Residual Stones After Percutaneous Nephrolithotomy

NCT07523074 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 476

Last updated 2026-04-13

No results posted yet for this study

Summary

Residual renal stone fragments remain a common clinical issue following percutaneous nephrolithotomy (PCNL), with reported incidence ranging from 10% to 30%. These fragments may act as a nidus for recurrent stone formation, infection, or obstruction, necessitating further intervention. Extracorporeal shock wave lithotripsy (ESWL) is widely used as a non-invasive treatment option for such residual stones; however, the optimal timing of ESWL after PCNL remains unclear.

Early application of ESWL may enhance stone clearance before fragment embedding or encrustation occurs, but it could be associated with increased risk of bleeding or infection due to incomplete renal healing. Conversely, delayed ESWL allows for better tissue recovery but may permit stone growth or persistence of symptoms.

This prospective randomized comparative study aims to evaluate the optimal timing of ESWL after PCNL in patients with residual renal stones ≤15 mm. Eligible patients will be randomized into two groups: early ESWL (within 7-14 days after PCNL) and delayed ESWL (after 3-4 weeks). The primary outcome is the stone-free rate at 3 months, while secondary outcomes include complication rates, pain scores, renal function changes, and the need for additional interventions.

The results of this study are expected to provide evidence-based guidance on the ideal timing of ESWL following PCNL to maximize efficacy and minimize complications.

Conditions

  • Nephrolithiasis

Interventions

PROCEDURE

Extracorporeal shock wave lithotripsy (ESWL)

Extracorporeal shock wave lithotripsy (ESWL) is performed using a standardized protocol for treatment of residual renal stones ≤15 mm after percutaneous nephrolithotomy (PCNL). All patients are treated using the same lithotripter model with standardized energy settings and shock frequency according to EAU guidelines. Sedation is administered as needed. A maximum of three ESWL sessions is allowed. Follow-up imaging is performed to assess stone clearance.

Sponsors & Collaborators

  • Beni-Suef 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
2025-12-02
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07523074 on ClinicalTrials.gov