Clinical trial NCT04557722: The Newly Reported (0-90°) Versus (0-30°) Biplanar Fluoroscopic Puncture Technique in PCNL
Official title: The Newly Reported (0-90°) Versus (0-30°) Biplanar Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrolithotomy, Percutaneous
Kidney Stone
PCNL
Keywords: PCNL
0-30º Biplanar
new 0-90º
PCNL puncture techniques
090 PCNL
030 PCNL
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The puncture success rate and number of attempts
timeFrame: intraoperative
Secondary outcomes:
measure: The Puncture fluoroscopy screening time
timeFrame: intraoperative
measure: Intraoperative puncture complications
timeFrame: intraoperative
Other outcomes:
Locations:
city: Menoufia
country: Egypt
facility: MenoufiaU
state: Shebin El-kom
Study officials:
affiliation: Menoufia University
name: Mohamed Elshazly, MD
role: STUDY_DIRECTOR
affiliation: Menoufia University
name: Mohamed Kamal Omar, MD
role: STUDY_DIRECTOR
affiliation: Menoufia University
name: Eid El Sherif, MD
role: STUDY_DIRECTOR
affiliation: Menoufia University
name: Mohamed Aziz, MD
role: STUDY_DIRECTOR
References: