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Safety and Efficacy of Papillary Versus NonPapillary Access During Percutaneous Nephrolithotomy

ConditionsSafetyEfficacyPapillaryNonPapillaryPercutaneous Nephrolithotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

This study aims to evaluate and compare the safety, efficacy, and clinical outcomes of papillary and non-papillary renal access during percutaneous nephrolithotomy (PCNL), and to determine whether non-papillary puncture can be considered a safe and effective alternative to the conventional papillary approach in selected patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Solitary or multiple renal calculi ≥2 cm

Ability to provide informed consent

Disqualifiers

Bleeding diathesis or uncorrected coagulopathy

Active urinary tract infection at the time of surgery

Congenital anomalies severely distorting renal anatomy (e.g., horseshoe kidney, ectopic kidney)

Morbid obesity [body mass index (BMI) ≥ 40] limiting safe positioning

Trial design

Design model

Parallel

Treatments tested in this trial

  • Papillary access puncture

    Procedure/Surgery

    Patients will undergo papillary access puncture (Control group)

  • Non-papillary access puncture

    Procedure/Surgery

    Patients will undergo non-papillary access puncture

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stone-free rate

Stone-free rate will be assessed at 4 weeks postoperatively using non-contrast computed tomography (CT). It will be defined as the absence of residual stones or the presence of clinically insignificant residual fragments (asymptomatic, non-obstructive fragments 2:3mm).

Time frame
4 weeks postoperatively

Secondary outcomes

1

Incidence of complication

Incidence of complication will be assessed using ClavienDindo classification. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Allowed treatments include antiemetics, antipyretics, analgesics, diuretics, electrolytes, physiotherapy, and opening wound infections at the bedside. Grade II: Requiring pharmacological treatment with drugs other than those allowed for Grade I complications. Blood transfusions and total parenteral nutrition (TPN) are also included in this grade. Grade III: Requiring surgical, endoscopic, or radiological intervention. Grade IV: Life-threatening complication (including central nervous system complications) requiring intermediate Grade V: Death of the patient.

Time frame
4 weeks postoperatively
2

Operative time

Operative time will be recorded from start of the surgery till the end of surgery.

Time frame
Intraoperatively
3

Fluoroscopy time

Total fluoroscopy time during the procedure will be measured.

Time frame
Intraoperatively
4

Hemoglobin drop

Difference in hemoglobin level between the preoperative and postoperative measurements will be recorded.

Time frame
24 hours after the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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