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Completed

NCT Number: NCT07279389

Comparative Study Between One-Shot Dilatation Versus Serial Dilatation Techniques for Access in Percutaneous Nephrolithotomy in Adult Patients

This comparative study aims to compare and assess the safety, efficacy, outcome, feasibility, intraoperative and postoperative complications of one-shot dilatation versus serial dilatation techniques for access during percutaneous nephrolithotomy for management of renal stone disease in adult patients.

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Key information

Conditions

Percutaneous Nephrolithotomy (PCNL) Renal Stone Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Cairo Governorate, 11865, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 18 and 70 years.
  • Patients with renal stones which their size in maximum diameter is more than 2cm and indicated for percutaneous nephrolithotomy.
  • Patients clinically fit for surgery.
  • Patients with normal anatomy of urinary tract.
  • Patients able to understand the procedure and accept to sign the informed consent.

Exclusion criteria

  • Patients aged below 18 or above 70 years.
  • Patients with renal stones which their size in maximum diameter is less than 2cm or contraindicated for endoscopic management.
  • Patients with urinary tract infection, abnormal coagulopathy state or clinically unfit for surgery.
  • Patients with nephrostomy tube in situ.
  • Patients with more than single access tract.
  • Patients undergoing simultaneous bilateral stone procedures.
  • Patients with urinary tract abnormalities or history of renal transplantation.
  • Renal insufficiency with serum creatinine above 3.0mg/dL
  • Patients unable to understand the procedure or refuse to sign the informed consent.

Treatment and study plan

renal dilatation by one-shot dilatation technique

Procedure

renal dilatation was done by one-shot dilatation technique using 30Fr Amplatz dilator directly over the central Alken rod.

renal dilatation by metallic telescopic dilators (Alken).

Procedure

insertion of the Alken guide followed by a telescopic dilator between 9Fr to 30Fr, then an Amplatz sheath 30Fr was advanced over the dilator which was then removed, leaving the Amplatz sheath in the collecting system

renal dilatation by sequential fascial dilators (Amplatz)

Procedure

sequential renal dilatation with Amplatz dilator set was used

Primary outcomes

  1. Mean Fluoroscopy time

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. Mean access time

    Time frame: From enrollment to the end of treatment at 8 weeks

  3. Stone free rate

    Time frame: From enrollment to the end of treatment at 8 weeks

  4. Hospitalization Period

    Time frame: From enrollment to the end of treatment at 8 weeks

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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