Safety and Efficacy of Papillary Versus NonPapillary Access During Percutaneous Nephrolithotomy

NCT07855354 | Recruiting

• 1 other identifier: FMASU MS 480/2026
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Safety; Efficacy; Papillary; NonPapillary; Percutaneous Nephrolithotomy

Outcome Measures

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).

  4 weeks postoperatively

Secondary Outcomes (6)

• Incidence of complication

  4 weeks postoperatively

• Operative time

  Intraoperatively

• Fluoroscopy time

  Intraoperatively

• Hemoglobin drop

  24 hours after the procedure

• Need for blood transfusion

  24 hours after the procedure

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients will undergo papillary access puncture (Control group)

Procedure: Papillary access puncture

Group B

EXPERIMENTAL

Patients will undergo non-papillary access puncture

Procedure: Non-papillary access puncture

Interventions

Papillary access puncture PROCEDURE

Patients will undergo papillary access puncture (Control group)

Group A

Non-papillary access puncture PROCEDURE

Patients will undergo non-papillary access puncture

Group B

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Solitary or multiple renal calculi ≥2 cm
• Ability to provide informed consent

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

Central Study Contacts

Mohamed I El-Sayed, MBBCH

CONTACT

00201068569307; 29709041800133@med.asu.edu.eg

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: Resident of Urology, Faculty of Medicine, Ain Shams University, Cairo, Egypt

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)