Nephrolithotomy, PercutaneousNCT06837883
The Impact of Through-and-through Guidewire on Percutaneous Nephrolithotomy
A study testing Percutaneous nephrolithotomy through and through guiedwire and Standard percutaneous nephrolithotomy in people with Nephrolithotomy, Percutaneous, run by South Valley University at 1 site in Egypt.
Trial summary
The aim to the study is to investigate the impact of combined retrograde and antegrade insertion of a through-and-through guidewire during percutaneous nephrolithotomy (PCNL). Adult patients with complex renal stones (Guy's stone score III, IV) were ranomized between standard PCNL (control group) and PCNL with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nephrolithotomy, Percutaneous
- What is being tested?
- Percutaneous nephrolithotomy through and through guiedwire and Standard percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients without contraindications for PCNL with Guy's stone score III-IV were randomized to either standard PCNL (control group) or PCNL with retrograde and antegrade inserted through-and-through guidewire (study group)
Who cannot join
- solitary or solitary functioning kidney, renal congenital anomlalies, and urinary diversion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Through-and-through Guidewire on the Outcome of Percutaneous Nephrolithotomy (PCNL) in Complex Renal Stones: a Randomized Controlled Study
The aim to the study is to investigate the impact of combined retrograde and antegrade insertion of a through-and-through guidewire during percutaneous nephrolithotomy (PCNL). Adult patients with complex renal stones (Guy's stone score III, IV) were ranomized between standard PCNL (control group) and PCNL with comibined retrograde and antegrade inserted through-and-through guidewire (study group). This modification initially involves the retrograde insertion of an additional guidewire beside the ureteral catheter. After percutaneous puncture and dilation of the tract, the guidewire is pulled antegrade through the renal access, using either ureteroscopy or nephroscopy to secure the tract throughout the procedure.The primary outcome is to compare the initial stone free rate (SFR) between both groups. The secondary outcome is to compare both groups as regard operative time, fluorscopy time, number of tracts, haemoglobin drop, blood transfusion and major complications accoridng to Clavien-Dindo (CD) system. Success is defined as presence of insignificant residual less than 4 mm.
Read the detailed description
Intervention All patients underwent PCNL under general anesthesia. In the control group, the procedure began with the insertion of a ureteral catheter in the lithotomy position, followed by percutaneous renal puncture in the prone position under fluoroscopic guidance. A nitinol-PTFE hybrid guidewire was inserted through the needle and initially guided towards the ureter, with difficulty entering the ureter, tract dilation was performed according to the guidewire position. Tracts were dilated to 28Fr using Alken's dilators and a 24-F rigid nephroscopy (Karl Storz, Germany) was used. Stones were disintegrated with pneumatic lithotripsy (Swiss Lithoclast Master, EMS, Nyon, Switzerland) and fragments were extracted with forceps or stone basket. For inacessible stones, a flexible cystoscopy (Karl Storz, Flex X2, GmbH) and laser disintegration was used (holmium:YAG laser: Versa Pulse PowerSuit 20 W; Lumenis Inc., Dreieich-Dreieichenhain, Germany). If it was difficult to reach the stones with the flexible nephroscopy, additional tracts were used. At the end of the procedure, an 18-20 F nephrostomy tube was left in each tract for 24-48 hours. In some cases where the pelvic-caecal system is injured or multiple significant residuals are present, an antegrade DJ stent is placed by withdrawing the ureteral catheter and inserting a guidewire up to the bladder to then replace the ureteral catheter with a DJ stent.
In the study group, a modification was carried out to have through-and-through guidewire. The procedure begins with the retrograde insertion of 2 guidewires, followed by the insertion of the ureteral catheter via one of the two guidewires. Percutaneous access is performed as usual. Using rigid nephroscopy or ureteroscopy, the guidewire was pulled antegrade through the access sheath to create a through-and-through guidewire. If it is difficult to access the guidewire, stone fragmentation is initiated and the guidewire is pulled out during the procedure. Otherwise, the procedure is performed as described above. If a post-operative DJ stent is required, we use the through-and-through guidewire directly for insertion.
Surgical data such as operative time starting by the percutaneous puncture, total fluoroscopy time, number of tracts and complications are recorded. On the on the 1st postoperative day, both US and plain X-rays were used to assess stone free rate for the radiopaque stones, while for radiolucent stone NCCT is used.
- Conditions
- Nephrolithotomy, Percutaneous
- Being tested
- Percutaneous nephrolithotomy through and through guiedwire, Standard percutaneous nephrolithotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrolithotomy through and through guiedwireProcedure or surgery
In the study group, a modification in percutaneous nephrolithotomy was carried out to have through-and-through guidewire.
Standard percutaneous nephrolithotomyProcedure or surgery
Standard percutaneous nephrolithotomy without using through and through guide wire
| Study group | Role | What they receive |
|---|---|---|
| Study group using through and through guiedwire | Experimental | In the study group, a modification was carried out to have through-and-through guidewire. The procedure begins with the retrograde insertion of 2 guidewires, followed by the insertion of the ureteral catheter via one of the two guidewires. Percutaneous access is performed as usual. Using rigid nephroscopy or ureteroscopy, the guidewire was pulled antegrade through the access sheath to create a through-and-through guidewire. If it is difficult to access the guidewire, stone fragmentation is initiated and the guidewire is pulled out during the procedure. Otherwise, the procedure is performed as described above. If a post-operative DJ stent is required, we use the through-and-through guidewire directly for insertion. Receives: Procedure: Percutaneous nephrolithotomy through and through guiedwire |
| Standard percutaneous nephrolithotomy | Active comparator | In the control group, the procedure began with the insertion of a ureteral catheter in the lithotomy position, followed by percutaneous renal puncture in the prone position under fluoroscopic guidance. A nitinol-PTFE hybrid guidewire was inserted through the needle and initially guided towards the ureter, with difficulty entering the ureter, tract dilation was performed according to the guidewire position. Tracts were dilated to 28Fr using Alken's dilators and a 24-F rigid nephroscopy (Karl Storz, Germany) was used. Stones were disintegrated with pneumatic lithotripsy (Swiss Lithoclast Master, EMS, Nyon, Switzerland) and fragments were extracted with forceps or stone basket. For inacessible stones, a flexible cystoscopy (Karl Storz, Flex X2, GmbH) and laser disintegration was used (holmium:YAG laser: Versa Pulse PowerSuit 20 W; Lumenis Inc., Dreieich-Dreieichenhain, Germany). Receives: Procedure: Standard percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate (SFR) between both groups
Measured: within one week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
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.
- 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Mahmoud, South Valley University
- Investigators
- Osama Mahmoud, Dr., Principal investigator, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837883
- Sponsor's protocol ID
- URO016/4/624
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the the individual data collected during the trial will be available, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Through-and-through Guidewire on the Outcome of Percutaneous Nephrolithotomy (PCNL) in Complex Renal Stones: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06837883
- Acronym / sponsor ID
- URO016/4/624
- Conditions
- Nephrolithotomy, Percutaneous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 20 Feb 2025 (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.
The aim to the study is to investigate the impact of combined retrograde and antegrade insertion of a through-and-through guidewire during percutaneous nephrolithotomy (PCNL). Adult patients with complex renal stones (Guy's stone score III, IV) were ranomized between standard PCNL (control group) and PCNL with comibined retrograde and antegrade inserted through-and-through guidewire (study group). This modification initially involves the retrograde insertion of an additional guidewire beside the ureteral catheter. After percutaneous puncture and dilation of the tract, the guidewire is pulled antegrade through the renal access, using either ureteroscopy or nephroscopy to secure the tract throughout the procedure.The primary outcome is to compare the initial stone free rate (SFR) between both groups. The secondary outcome is to compare both groups as regard operative time, fluorscopy time, number of tracts, haemoglobin drop, blood transfusion and major complications accoridng to Clavien-Dindo (CD) system. Success is defined as presence of insignificant residual less than 4 mm.
Detailed description
Intervention All patients underwent PCNL under general anesthesia. In the control group, the procedure began with the insertion of a ureteral catheter in the lithotomy position, followed by percutaneous renal puncture in the prone position under fluoroscopic guidance. A nitinol-PTFE hybrid guidewire was inserted through the needle and initially guided towards the ureter, with difficulty entering the ureter, tract dilation was performed according to the guidewire position. Tracts were dilated to 28Fr using Alken's dilators and a 24-F rigid nephroscopy (Karl Storz, Germany) was used. Stones were disintegrated with pneumatic lithotripsy (Swiss Lithoclast Master, EMS, Nyon, Switzerland) and fragments were extracted with forceps or stone basket. For inacessible stones, a flexible cystoscopy (Karl Storz, Flex X2, GmbH) and laser disintegration was used (holmium:YAG laser: Versa Pulse PowerSuit 20 W; Lumenis Inc., Dreieich-Dreieichenhain, Germany). If it was difficult to reach the stones with the flexible nephroscopy, additional tracts were used. At the end of the procedure, an 18-20 F nephrostomy tube was left in each tract for 24-48 hours. In some cases where the pelvic-caecal system is injured or multiple significant residuals are present, an antegrade DJ stent is placed by withdrawing the ureteral catheter and inserting a guidewire up to the bladder to then replace the ureteral catheter with a DJ stent.
In the study group, a modification was carried out to have through-and-through guidewire. The procedure begins with the retrograde insertion of 2 guidewires, followed by the insertion of the ureteral catheter via one of the two guidewires. Percutaneous access is performed as usual. Using rigid nephroscopy or ureteroscopy, the guidewire was pulled antegrade through the access sheath to create a through-and-through guidewire. If it is difficult to access the guidewire, stone fragmentation is initiated and the guidewire is pulled out during the procedure. Otherwise, the procedure is performed as described above. If a post-operative DJ stent is required, we use the through-and-through guidewire directly for insertion.
Surgical data such as operative time starting by the percutaneous puncture, total fluoroscopy time, number of tracts and complications are recorded. On the on the 1st postoperative day, both US and plain X-rays were used to assess stone free rate for the radiopaque stones, while for radiolucent stone NCCT is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group using through and through guiedwire | Experimental | Procedure: Percutaneous nephrolithotomy through and through guiedwireIn the study group, a modification was carried out to have through-and-through guidewire. The procedure begins with the retrograde insertion of 2 guidewires, followed by the insertion of the ureteral catheter via one of the two guidewires. Percutaneous access is performed as usual. Using rigid nephroscopy or ureteroscopy, the guidewire was pulled antegrade through the access sheath to create a through-and-through guidewire. If it is difficult to access the guidewire, stone fragmentation is initiated and the guidewire is pulled out during the procedure. Otherwise, the procedure is performed as described above. If a post-operative DJ stent is required, we use the through-and-through guidewire directly for insertion. |
| Standard percutaneous nephrolithotomy | Active comparator | Procedure: Standard percutaneous nephrolithotomyIn the control group, the procedure began with the insertion of a ureteral catheter in the lithotomy position, followed by percutaneous renal puncture in the prone position under fluoroscopic guidance. A nitinol-PTFE hybrid guidewire was inserted through the needle and initially guided towards the ureter, with difficulty entering the ureter, tract dilation was performed according to the guidewire position. Tracts were dilated to 28Fr using Alken's dilators and a 24-F rigid nephroscopy (Karl Storz, Germany) was used. Stones were disintegrated with pneumatic lithotripsy (Swiss Lithoclast Master, EMS, Nyon, Switzerland) and fragments were extracted with forceps or stone basket. For inacessible stones, a flexible cystoscopy (Karl Storz, Flex X2, GmbH) and laser disintegration was used (holmium:YAG laser: Versa Pulse PowerSuit 20 W; Lumenis Inc., Dreieich-Dreieichenhain, Germany). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients without contraindications for PCNL with Guy's stone score III-IV were randomized to either standard PCNL (control group) or PCNL with retrograde and antegrade inserted through-and-through guidewire (study group)
Key exclusion criteria (1 listed)
- solitary or solitary functioning kidney, renal congenital anomlalies, and urinary diversion.
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 |
|---|---|---|
| Percutaneous nephrolithotomy through and through guiedwireIn the study group, a modification in percutaneous nephrolithotomy was carried out to have through-and-through guidewire. | Procedure or surgery | Study group using through and through guiedwire |
| Standard percutaneous nephrolithotomyStandard percutaneous nephrolithotomy without using through and through guide wire | Procedure or surgery | Standard percutaneous nephrolithotomy |
Primary outcome
Stone free rate (SFR) between both groups
Time frame: within one week postoperative
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 20 Feb 2025.
- Individual participant dataSharing planned: Yes. All the the individual data collected during the trial will be available, after deidentification
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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.
Osama Mahmoud, Dr. principal investigator
South Valley 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 Percutaneous nephrolithotomy through and through guiedwire and Standard percutaneous nephrolithotomy in people with Nephrolithotomy, Percutaneous, run by South Valley 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 1 inclusion and 1 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 20 Feb 2025. 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?
Stone free rate (SFR) between both groups (time frame: within one week postoperative). 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 20 Feb 2025.