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

NCT07279389 | Completed

• 1 other identifier: FMASU MS133/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Percutaneous Nephrolithotomy (PCNL); Renal Stone Disease

Keywords

Percutaneous Nephrolithotomy

Outcome Measures

Primary Outcomes (4)

• Mean Fluoroscopy time

  From enrollment to the end of treatment at 8 weeks

• Mean access time

  From enrollment to the end of treatment at 8 weeks

• Stone free rate

  From enrollment to the end of treatment at 8 weeks

• Hospitalization Period

  From enrollment to the end of treatment at 8 weeks

Study Arms (3)

Patients receiving renal dilatation by one-shot dilatation technique

ACTIVE COMPARATOR

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

Procedure: renal dilatation by one-shot dilatation technique

Patients receiving renal dilatation by metallic telescopic dilators (Alken).

ACTIVE COMPARATOR

Procedure: renal dilatation by metallic telescopic dilators (Alken).

Patients receiving renal dilatation by sequential fascial dilators (Amplatz).

ACTIVE COMPARATOR

Procedure: renal dilatation by sequential fascial dilators (Amplatz)

Interventions

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

Patients receiving renal dilatation by metallic telescopic dilators (Alken).

renal dilatation by sequential fascial dilators (Amplatz) PROCEDURE

sequential renal dilatation with Amplatz dilator set was used

Patients receiving renal dilatation by sequential fascial dilators (Amplatz).

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.

Patients receiving renal dilatation by one-shot dilatation technique

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 11865, Egypt

Location

Related Publications (1)

• Alken P, Hutschenreiter G, Gunther R, Marberger M. Percutaneous stone manipulation. J Urol. 1981 Apr;125(4):463-6. doi: 10.1016/s0022-5347(17)55073-9.

  PMID: 7218439 BACKGROUND

Study Officials

• Hisham Arafa, Consultant

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: February 27, 2022
• Primary Completion: August 27, 2022
• Study Completion: August 5, 2023
• Last Updated: December 12, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)