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

June 1, 2022 updated by: Ahmed Zakaria Ali Ibrahim Alshahawy, Menoufia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Shebin El-kom
      • Menoufia, Shebin El-kom, Egypt, 32511
        • MenoufiaU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: 0-30° technique.
Procedure: 0-30° Biplanar Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy.
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.
Active Comparator: Group 2: new 0-90° technique.
Procedure: new 0-90° Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The puncture success rate and number of attempts
Time Frame: intraoperative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Puncture fluoroscopy screening time
Time Frame: intraoperative
assessed on the monitor of C-Arm.
intraoperative
Intraoperative puncture complications
Time Frame: intraoperative

  1. 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.
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Investigators

  • Study Director: Mohamed Elshazly, MD, Menoufia University
  • Study Director: Mohamed Kamal Omar, MD, Menoufia University
  • Study Director: Eid El Sherif, MD, Menoufia University
  • Study Director: Mohamed Aziz, MD, Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2021

Primary Completion (Actual)

April 17, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • New 0-90° Vs 0-30° in PCNL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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