Nephrolithotomy, PercutaneousNCT04557722
The Newly Reported (0-90°) Versus (0-30°) Biplanar Fluoroscopic Puncture Technique in PCNL
A study testing 0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy and New 0-90° Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy in people with Nephrolithotomy, Percutaneous and Kidney Stone, run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithotomy, Percutaneous, Kidney Stone, PCNL
- What is being tested?
- 0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy and New 0-90° Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 24 May 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient over 18 years old.
- Renal stone 2 cm or greater.
Who cannot join
- A patient < 18 years old.
- Congenital anomalies of the kidney: horseshoe kidney, malrotated kidney, pelvic ectopic kidney.
- Patient with obvious spinal deformity.
- Coagulopathies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- 0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy, New 0-90° Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy
- Keywords
- PCNL, 0-30º Biplanar, new 0-90º, PCNL puncture techniques, 090 PCNL, 030 PCNL
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous NephrolithotomyProcedure or surgery
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.
New 0-90° Fluoroscopic Puncture Techniques for Percutaneous NephrolithotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 0-30° technique. | Active comparator | Procedure: 0-30° Biplanar Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy. Receives: Procedure: 0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy |
| Group 2: new 0-90° technique. | Active comparator | Procedure: new 0-90° Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy. Receives: Procedure: New 0-90° Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: intraoperative
Secondary outcomes (2)
The Puncture fluoroscopy screening time
assessed on the monitor of C-Arm.
Measured: intraoperative
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.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start24 May 2021
- Primary completion17 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrolithotomy, PercutaneousStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zakaria Ali Ibrahim Alshahawy, Menoufia University
- Investigators
- Mohamed Elshazly, MD, Study director, Menoufia UniversityMohamed Kamal Omar, MD, Study director, Menoufia UniversityEid El Sherif, MD, Study director, Menoufia UniversityMohamed Aziz, MD, Study director, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557722
- Sponsor's protocol ID
- New 0-90° Vs 0-30° in PCNL
- Status last verified
- Jun 2022
- First submitted
- 15 Sep 2020
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Newly Reported (0-90°) Versus (0-30°) Biplanar Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04557722
- Acronym / sponsor ID
- New 0-90° Vs 0-30° in PCNL
- Conditions
- Nephrolithotomy, Percutaneous, Kidney Stone, PCNL
- Keywords
- PCNL, 0-30º Biplanar, new 0-90º, PCNL puncture techniques, 090 PCNL, 030 PCNL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 17 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: 0-30° technique. | Active comparator | Procedure: 0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous NephrolithotomyProcedure: 0-30° Biplanar Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy. |
| Group 2: new 0-90° technique. | Active comparator | Procedure: New 0-90° Fluoroscopic Puncture Techniques for Percutaneous NephrolithotomyProcedure: new 0-90° Fluoroscopic Puncture Technique for Percutaneous Nephrolithotomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A patient over 18 years old.
- Renal stone 2 cm or greater.
Key exclusion criteria (4 listed)
- A patient < 18 years old.
- Congenital anomalies of the kidney: horseshoe kidney, malrotated kidney, pelvic ectopic kidney.
- Patient with obvious spinal deformity.
- Coagulopathies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomyafter retrograde instillation of contrast through the ureteric catheter; the puncture of the desired calyx by using the 0-30 degree technique of C-Arm. | Procedure or surgery | Group 1: 0-30° technique. |
| New 0-90° Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomyafter retrograde instillation of contrast through the ureteric catheter; the puncture of the desired calyx by using the 0-90 degree technique of C-Arm. | Procedure or surgery | Group 2: new 0-90° technique. |
Primary outcome
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).
2 secondary outcomes
The Puncture fluoroscopy screening time
Time frame: intraoperative
Intraoperative puncture complications
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Nephrolithotomy, Percutaneous
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Recruiting
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Kidney Stone
Recruiting
Supine vs. Prone Mini-PCNL in Children
Kidney Calculi (or Renal Calculi / Nephrolithiasis), Supine Mini Percutaneous Nephrolithotomy
Recruiting
Nephrostomy Tract Infiltration for Pain Control After PCNL
Postoperative Pain, Kidney Calculi
Not yet recruitingPhase 4
Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy
Nephrolithiasis, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Elshazly, MD study director
Menoufia University
Mohamed Kamal Omar, MD study director
Menoufia University
Eid El Sherif, MD study director
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy and New 0-90° Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy in people with Nephrolithotomy, Percutaneous and Kidney Stone, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The puncture success rate and number of attempts (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.