Kidney Function TestsNCT05232188
Effect of Renal Access Sheath on Functions
A study testing Percutaneous nephrolithotomy in people with Kidney Function Tests and Treatment Outcome, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients will be randomly divided into two groups in order to evaluate the effect of the size of the access sheath (Amplatz) used in the Percutaneous Nephrolithotomy (PCNL) operation on kidney functions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Function Tests, Treatment Outcome
- What is being tested?
- Percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 1 Jan 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with 2-3 cm kidney stones
- Patients with an American Society of Anesthesiologists ≤2 score
- BMI: Patients between 20 and 35 kg/m2
Who cannot join
- Patients with preoperative renal failure
- Patients with multiple access
- Patients undergone renal transplantation
- Patients with renal anomalies (horseshoe kidney, solitary kidney, double collecting system, etc.)
- Patients with history of open kidney stones surgery and/or PCNL history
- Patients who cannot be stone-free in the postoperative period (fragments >4 mm in imaging) and require additional treatment intervention
Show all 11Show fewer
- Patients with bleeding disorders
- Pregnant patients
- Patients with complete staghorn stones
- Patients with bilateral obstructive stones
- Patients with active infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul
About this study
Official title: The Effect of Renal Access Sheath Size Used During Percutaneous Nephrolithotomy on Postoperative Renal Functions
Patients will be randomly divided into two groups in order to evaluate the effect of the size of the access sheath (Amplatz) used in the Percutaneous Nephrolithotomy (PCNL) operation on kidney functions. After dilatation, 22French (Fr) Amplatz sheath will be placed in the first group, while 28Fr Amplatz sheath will be placed in the second group.
The functional difference will be evaluated with preoperative and postoperative 3rd-month kidney scintigraphies (diethylenetriamine pentaacetic acid (DTPA) and technetium-99m dimercaptosuccinic acid (DMSA). In addition, Kidney Injury Molecule-1 (KIM-1) levels will be measured in the urine in order to be a predictor of functional loss in the early period.
Read the detailed description
PCNL has been applied for the last 30 years as the primary and most effective treatment method in patients with kidney stones of 2 cm or larger. The primary purpose of the operation is to ensure stone-freeness. Another aim is to keep the damage to kidney functions to a minimum, thanks to the endoscopic intervention. In this respect, PCNL is superior to open surgery and reduces morbidity.
Renal access, dilatation, and fragmentation are the 3 important stages of the operation, and access and dilation significantly affect the final results of PCNL. The size of the access sheath used as a result of dilation determines the size of the tract where the endoscopic intervention will be made, and not only affects the postoperative results and success but also determines the factors that may affect the kidney functions such as bleeding and loss of parenchyma in the kidney.
There are studies showing that less bleeding, shorter hospital stay, and better postoperative pain control are achieved with the reduction of access sheath size. In addition to conventional PCNL, methods such as mini PCNL, micro PCNL, ultra-mini PCNL, and tubeless PCNL, where the diameter of the access sheath and endoscope are gradually decreasing, both increase success and reduce morbidity.
In our study, in order to examine the postoperative functional results of 22 Fr and 28 Fr accessory sheath size;
- For the early period, the change in KIM-1 values, a validated biomarker in acute kidney injury, measured on the preoperative and postoperative day 1 will be proportioned between the groups,
- For the late period, we aimed to compare the kidney functions in the mid-long term by proportioning the DMSA and DTPA values at the preoperative and postoperative 3rd month.
- Conditions
- Kidney Function Tests, Treatment Outcome
- Being tested
- Percutaneous nephrolithotomy
- Keywords
- Percutaneous nephrolithotomy, Amplatz sheath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrolithotomyProcedure or surgery
percutaneous nephrolithotomy surgery, 22F amplatz sheath is used in one group, while 28F amplatz sheath is used in the other group.
| Study group | Role | What they receive |
|---|---|---|
| 22French (Fr) | Experimental | After renal access, dilatation is provided up to 22Fr with a dilatator set, and fragmentation is started with a 19Fr nephroscope. Receives: Procedure: Percutaneous nephrolithotomy |
| 28F | Experimental | After renal access, dilatation is provided up to 28Fr with a dilatator set, and fragmentation is started with a 25Fr nephroscope. Receives: Procedure: Percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential function changes
Differential function changes in the operated kidney in postoperative DMSA and DTPA
Measured: 3 months
Newly developed scar
Presence of newly developed scar in DMSA
Measured: 3 months
KIM-1
Change in urinary KIM-1 levels
Measured: 24 hours
Secondary outcomes (4)
Creatinine
Postoperative changes in creatinine
Measured: 24 hours
Glomerular filtration rate
Postoperative changes in glomerular filtration rate
Measured: 24 hours
Stone-free rate
Postoperative stone-free rates
Measured: 24 hours
Complications
Complications according to Clavian grading
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Dec 2020
- Primary completion1 Dec 2022
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Function TestsStudies 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
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232188
- Sponsor's protocol ID
- NoyanOzluPCNL
- Status last verified
- Dec 2022
- First submitted
- 25 Nov 2021
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Renal Access Sheath Size Used During Percutaneous Nephrolithotomy on Postoperative Renal Functions
- ClinicalTrials.gov ID
- NCT05232188
- Acronym / sponsor ID
- NoyanOzluPCNL
- Conditions
- Kidney Function Tests, Treatment Outcome
- Keywords
- Percutaneous nephrolithotomy, Amplatz sheath
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 9 Feb 2022 (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.
Patients will be randomly divided into two groups in order to evaluate the effect of the size of the access sheath (Amplatz) used in the Percutaneous Nephrolithotomy (PCNL) operation on kidney functions. After dilatation, 22French (Fr) Amplatz sheath will be placed in the first group, while 28Fr Amplatz sheath will be placed in the second group.
The functional difference will be evaluated with preoperative and postoperative 3rd-month kidney scintigraphies (diethylenetriamine pentaacetic acid (DTPA) and technetium-99m dimercaptosuccinic acid (DMSA). In addition, Kidney Injury Molecule-1 (KIM-1) levels will be measured in the urine in order to be a predictor of functional loss in the early period.
Detailed description
PCNL has been applied for the last 30 years as the primary and most effective treatment method in patients with kidney stones of 2 cm or larger. The primary purpose of the operation is to ensure stone-freeness. Another aim is to keep the damage to kidney functions to a minimum, thanks to the endoscopic intervention. In this respect, PCNL is superior to open surgery and reduces morbidity.
Renal access, dilatation, and fragmentation are the 3 important stages of the operation, and access and dilation significantly affect the final results of PCNL. The size of the access sheath used as a result of dilation determines the size of the tract where the endoscopic intervention will be made, and not only affects the postoperative results and success but also determines the factors that may affect the kidney functions such as bleeding and loss of parenchyma in the kidney.
There are studies showing that less bleeding, shorter hospital stay, and better postoperative pain control are achieved with the reduction of access sheath size. In addition to conventional PCNL, methods such as mini PCNL, micro PCNL, ultra-mini PCNL, and tubeless PCNL, where the diameter of the access sheath and endoscope are gradually decreasing, both increase success and reduce morbidity.
In our study, in order to examine the postoperative functional results of 22 Fr and 28 Fr accessory sheath size;
- For the early period, the change in KIM-1 values, a validated biomarker in acute kidney injury, measured on the preoperative and postoperative day 1 will be proportioned between the groups,
- For the late period, we aimed to compare the kidney functions in the mid-long term by proportioning the DMSA and DTPA values at the preoperative and postoperative 3rd month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 22French (Fr) | Experimental | Procedure: Percutaneous nephrolithotomyAfter renal access, dilatation is provided up to 22Fr with a dilatator set, and fragmentation is started with a 19Fr nephroscope. |
| 28F | Experimental | Procedure: Percutaneous nephrolithotomyAfter renal access, dilatation is provided up to 28Fr with a dilatator set, and fragmentation is started with a 25Fr nephroscope. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with 2-3 cm kidney stones
- Patients with an American Society of Anesthesiologists ≤2 score
- BMI: Patients between 20 and 35 kg/m2
Key exclusion criteria (11 listed)
- Patients with preoperative renal failure
- Patients with multiple access
- Patients undergone renal transplantation
- Patients with renal anomalies (horseshoe kidney, solitary kidney, double collecting system, etc.)
- Patients with history of open kidney stones surgery and/or PCNL history
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 nephrolithotomypercutaneous nephrolithotomy surgery, 22F amplatz sheath is used in one group, while 28F amplatz sheath is used in the other group. | Procedure or surgery | 22French (Fr), 28F |
Primary outcome
Differential function changes
Time frame: 3 months
Differential function changes in the operated kidney in postoperative DMSA and DTPA
Newly developed scar
Time frame: 3 months
Presence of newly developed scar in DMSA
KIM-1
Time frame: 24 hours
Change in urinary KIM-1 levels
4 secondary outcomes
Creatinine
Time frame: 24 hours
Glomerular filtration rate
Time frame: 24 hours
Stone-free rate
Time frame: 24 hours
Complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Kidney Function Tests and Treatment Outcome, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Dec 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Differential function changes (time frame: 3 months). The study lists 3 primary outcomes in all. 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 13 Dec 2022.