The Impact of Through-and-through Guidewire on Percutaneous Nephrolithotomy

NCT06837883 | Completed

• 1 other identifier: URO016/4/624
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The aim to the study is to investigate the impact of combined retrograde and antegrade insertion of a through-and-through guidewire during percutaneous nephrolithotomy (PCNL). Adult patients with complex renal stones (Guy's stone score III, IV) were ranomized between standard PCNL (control group) and PCNL with comibined retrograde and antegrade inserted through-and-through guidewire (study group). This modification initially involves the retrograde insertion of an additional guidewire beside the ureteral catheter. After percutaneous puncture and dilation of the tract, the guidewire is pulled antegrade through the renal access, using either ureteroscopy or nephroscopy to secure the tract throughout the procedure.The primary outcome is to compare the initial stone free rate (SFR) between both groups. The secondary outcome is to compare both groups as regard operative time, fluorscopy time, number of tracts, haemoglobin drop, blood transfusion and major complications accoridng to Clavien-Dindo (CD) system. Success is defined as presence of insignificant residual less than 4 mm.

Conditions

Nephrolithotomy, Percutaneous

Outcome Measures

Primary Outcomes (1)

• Stone free rate (SFR) between both groups

  within one week postoperative

Study Arms (2)

Study group using through and through guiedwire

EXPERIMENTAL

In the study group, a modification was carried out to have through-and-through guidewire. The procedure begins with the retrograde insertion of 2 guidewires, followed by the insertion of the ureteral catheter via one of the two guidewires. Percutaneous access is performed as usual. Using rigid nephroscopy or ureteroscopy, the guidewire was pulled antegrade through the access sheath to create a through-and-through guidewire. If it is difficult to access the guidewire, stone fragmentation is initiated and the guidewire is pulled out during the procedure. Otherwise, the procedure is performed as described above. If a post-operative DJ stent is required, we use the through-and-through guidewire directly for insertion.

Procedure: Percutaneous nephrolithotomy through and through guiedwire

Standard percutaneous nephrolithotomy

ACTIVE COMPARATOR

In the control group, the procedure began with the insertion of a ureteral catheter in the lithotomy position, followed by percutaneous renal puncture in the prone position under fluoroscopic guidance. A nitinol-PTFE hybrid guidewire was inserted through the needle and initially guided towards the ureter, with difficulty entering the ureter, tract dilation was performed according to the guidewire position. Tracts were dilated to 28Fr using Alken's dilators and a 24-F rigid nephroscopy (Karl Storz, Germany) was used. Stones were disintegrated with pneumatic lithotripsy (Swiss Lithoclast Master, EMS, Nyon, Switzerland) and fragments were extracted with forceps or stone basket. For inacessible stones, a flexible cystoscopy (Karl Storz, Flex X2, GmbH) and laser disintegration was used (holmium:YAG laser: Versa Pulse PowerSuit 20 W; Lumenis Inc., Dreieich-Dreieichenhain, Germany).

Procedure: Standard percutaneous nephrolithotomy

Interventions

Percutaneous nephrolithotomy through and through guiedwire PROCEDURE

In the study group, a modification in percutaneous nephrolithotomy was carried out to have through-and-through guidewire.

Study group using through and through guiedwire

Standard percutaneous nephrolithotomy PROCEDURE

Standard percutaneous nephrolithotomy without using through and through guide wire

Standard percutaneous nephrolithotomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients without contraindications for PCNL with Guy's stone score III-IV were randomized to either standard PCNL (control group) or PCNL with retrograde and antegrade inserted through-and-through guidewire (study group)

You may not qualify if:

• solitary or solitary functioning kidney, renal congenital anomlalies, and urinary diversion.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Qena Faculty of Medicine

Qina, 83253, Egypt

Location

Study Officials

• Osama Mahmoud, Dr.

  South Valley University

  PRINCIPAL INVESTIGATOR

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: Dr.

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 20, 2025
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication without time limit
• Access Criteria: Anyone who wishes to access the data

Locations

EG (1)