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

Primary Purpose

Nephrolithotomy, Percutaneous, Kidney Stone, PCNL

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy
New 0-90° Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithotomy, Percutaneous focused on measuring PCNL, 0-30º Biplanar, new 0-90º, PCNL puncture techniques, 090 PCNL, 030 PCNL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MenoufiaU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1: 0-30° technique.

Group 2: new 0-90° technique.

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

The Puncture fluoroscopy screening time
assessed on the monitor of C-Arm.
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.

Full Information

First Posted
September 15, 2020
Last Updated
June 1, 2022
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT04557722
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
April 17, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithotomy, Percutaneous, Kidney Stone, PCNL
Keywords
PCNL, 0-30º Biplanar, new 0-90º, PCNL puncture techniques, 090 PCNL, 030 PCNL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: 0-30° technique.
Arm Type
Active Comparator
Arm Description
Procedure: 0-30° Biplanar Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy.
Arm Title
Group 2: new 0-90° technique.
Arm Type
Active Comparator
Arm Description
Procedure: new 0-90° Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy.
Intervention Type
Procedure
Intervention Name(s)
0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy
Intervention Description
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
Intervention Name(s)
New 0-90° Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The puncture success rate and number of attempts
Description
percentage of patients in whom the renal puncture achieving desired calyx (evaluated by adequate introduction of the guidewire, bright urine output and stone accessibility).
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
The Puncture fluoroscopy screening time
Description
assessed on the monitor of C-Arm.
Time Frame
intraoperative
Title
Intraoperative puncture complications
Description
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.
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Elshazly, MD
Organizational Affiliation
Menoufia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Kamal Omar, MD
Organizational Affiliation
Menoufia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eid El Sherif, MD
Organizational Affiliation
Menoufia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Aziz, MD
Organizational Affiliation
Menoufia University
Official's Role
Study Director
Facility Information:
Facility Name
MenoufiaU
City
Menoufia
State/Province
Shebin El-kom
ZIP/Postal Code
32511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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