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

NCT ID: NCT04557722

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-24
• Study Completion Date: 2022-05-01

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.

Conditions

Nephrolithotomy, Percutaneous; Kidney Stone; PCNL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: 0-30° technique.

Procedure: 0-30° Biplanar Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy.

Group Type: ACTIVE_COMPARATOR

0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy

Intervention Type: PROCEDURE

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.

Group 2: new 0-90° technique.

Procedure: new 0-90° Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy.

Group Type: ACTIVE_COMPARATOR

New 0-90° Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Zakaria Ali Ibrahim Alshahawy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Elshazly, MD

Role: STUDY_DIRECTOR

Menoufia University

Mohamed Kamal Omar, MD

Role: STUDY_DIRECTOR

Menoufia University

Eid El Sherif, MD

Role: STUDY_DIRECTOR

Menoufia University

Mohamed Aziz, MD

Role: STUDY_DIRECTOR

Menoufia University

Locations

MenoufiaU

Menoufia, Shebin El-kom, Egypt

Countries

Egypt

Other Identifiers

New 0-90° Vs 0-30° in PCNL

Identifier Type: -

Identifier Source: org_study_id