The Newly Reported (0-90°) Versus (0-30°) Biplanar Fluoroscopic Puncture Technique in PCNL

Kidney Stone Clinical Trial

Official title:

The Newly Reported (0-90°) Versus (0-30°) Biplanar Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy: Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557722
• Other study ID #: New 0-90° Vs 0-30° in PCNL
• Status: Completed
• Phase: N/A
• Start date: May 24, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2022
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To analyze and compare the puncture success rate, puncture fluoroscopy time and intraoperative puncture complications of two different puncture techniques; fluoroscopic bi-planar (0-30º) versus newly reported bi-planar (0-90º) technique in PCNL.

Description:

Nephrolithiasis is one of the most common urological diseases, it is a widespread and challenging issue for both patients and healthcare systems. It is responsible for a significant financial and psychological burden, with an increased incidence of disease. The EAU (European Association of Urology) Guidelines recommend percutaneous nephrolithotomy in patients with kidney stones >2 cm.

The most crucial step of the procedure is the precise puncture of the caliceal system. This can be accomplished by the use of fluoroscopy, ultrasound, or the combination of both and new other imaging modalities techniques. Among them, Fluoroscopy is the most common method for conducting the percutaneous puncture by urologists worldwide using multiple mono-planar or bi-planar fluoroscopic techniques.

However, all fluoroscopic approaches face the same limitation, which is the difficult interpretation of the three-dimensional renal anatomy based on the two-dimensional X-ray information. Another disadvantage is the amount of fluoroscopic radiation used. Surgeons, assistants, nurses and patients, however, all have to accept various levels of radiation exposure. Numerous researches have revealed that it is still harmful to the human body who is exposed to radiation frequently, although under the aegis of protective aprons and thyroid shields, thus the application is affected to varying degrees.

Fluoroscopic bi-planar techniques provide better information about the depth and direction of the collecting system than mono-planar methods. The most popular bi-planar methods described in the literature are the triangulation (0-30º), the "bull´s eye" technique and the less known bi-planar technique (The 0-90º technique) described by Dr. Paul Escovar. A newly published (0-90º) technique by Braulio O Manzo et al to increase the accuracy of calculating the needle path to the exact calyx depth and decreases its radiation exposure.

In the current study, the investigator aimed to compare two different renal access techniques; fluoroscopic 0-30 and modified 0-90 technique regarding success rate, fluoroscopy time and intraoperative puncture complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2022
• Est. primary completion date: April 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A patient over 18 years old.

• Renal stone 2 cm or greater.

Exclusion Criteria:

• A patient < 18 years old.

• Congenital anomalies of the kidney: horseshoe kidney, malrotated kidney, pelvic ectopic kidney.

• Patient with obvious spinal deformity.

• Coagulopathies.

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithotomy, Percutaneous
• PCNL

Intervention

Procedure:
• 0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy
after retrograde instillation of contrast through the ureteric catheter; the puncture of the desired calyx by using the 0-30 degree technique of C-Arm.
• New 0-90° Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy
after retrograde instillation of contrast through the ureteric catheter; the puncture of the desired calyx by using the 0-90 degree technique of C-Arm.

Locations

Country	Name	City	State
Egypt	MenoufiaU	Menoufia	Shebin El-kom

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The puncture success rate and number of attempts	percentage of patients in whom the renal puncture achieving desired calyx (evaluated by adequate introduction of the guidewire, bright urine output and stone accessibility).	intraoperative
Secondary	The Puncture fluoroscopy screening time	assessed on the monitor of C-Arm.	intraoperative
Secondary	Intraoperative puncture complications	Dye Extravasation: Mild extravasation of contrast.; Significant extravasation which obscure important anatomical detail and making accurate needle redirection impossible.; Puncture failure rate: when puncture failed on achieving desired calyx, conversion into another puncture technique will be made.; Bleeding: Mild intraoperative bleeding.; Significant bleeding.	intraoperative