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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04557722
Enrollment
60
Registered
2020-09-22
Start date
2021-05-24
Completion date
2022-05-01
Last updated
2022-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stone, Nephrolithotomy, Percutaneous, PCNL

Keywords

PCNL, 0-30º Biplanar, new 0-90º, PCNL puncture techniques, 090 PCNL, 030 PCNL

Brief 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.

Detailed 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.

Interventions

PROCEDURE0-30° 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.

PROCEDURENew 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.

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The puncture success rate and number of attemptsintraoperativepercentage of patients in whom the renal puncture achieving desired calyx (evaluated by adequate introduction of the guidewire, bright urine output and stone accessibility).

Secondary

MeasureTime frameDescription
The Puncture fluoroscopy screening timeintraoperativeassessed on the monitor of C-Arm.
Intraoperative puncture complicationsintraoperative1. Dye Extravasation: * Mild extravasation of contrast. * Significant extravasation which obscure important anatomical detail and making accurate needle redirection impossible. 2. Puncture failure rate: when puncture failed on achieving desired calyx, conversion into another puncture technique will be made. 3. Bleeding: * Mild intraoperative bleeding. * Significant bleeding.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026