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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeni-Suef University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years.

Single or multiple residual renal stones ≤15 mm after PCNL.

Normal renal function (serum creatinine <1.5 mg/dL).

No active UTI.

Disqualifiers

Bleeding disorders or anticoagulant therapy.

Obstructed drainage or active sepsis.

Stones >15 mm or requiring secondary PCNL.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Extracorporeal shock wave lithotripsy (ESWL)

    Procedure/Surgery

    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.

Treatment groups

476 Participants
are divided into 2 treatment groups
Group A: (Early ESWL): ESWL within 7-14 days after PCNLExperimental treatment 1 intervention
Group B: (Delayed ESWL): ESWL after 3-4 weeks.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stone-Free Rate at 3 Months

The proportion of patients who are stone-free, defined as no residual fragments greater than 2 mm on imaging (ultrasound or CT scan) at 3 months after ESWL treatment.

Time frame
3 months after ESWL

Secondary outcomes

1

Complication Rate

The incidence of postoperative complications including hematuria, fever, and urinary tract infection following ESWL treatment.

Time frame
Within 4 weeks after ESWL

Other outcomes

Sponsors and contacts

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