Renal CalculiNCT03614247
Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones
A study testing Retrograde intrarenal surgery, Micro-PNL and Ultra-mini PNL in people with Renal Calculi, run by Ankara Training and Research Hospital.
Trial summary
The aim of the present study to perform a full cost analysis for the complete clearance of calyceal stones by retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) for the treatment of lower calyceal stones between 1 and 2 centimeters (cm) in size. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Calculi
- What is being tested?
- Retrograde intrarenal surgery, Micro-PNL and Ultra-mini PNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 1 May 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had a lower calyceal stone between 1cm and 2 cm in size
Who cannot join
- solitary or anomaly (horseshoe or pelvic kidney) kidney,
- renal insufficiency,
- pregnancy,
- patient younger than 18 or older than 75 years,
- non-interrupted antithrombotic medication before surgery,
- urinary tract infection,
- double-j or nephrostomy insertion before surgery
About this study
Official title: Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones of 1 to 2 Centimeters: A Prospective, Randomized Study
The aim of the present study to perform a full cost analysis for the complete clearance of calyceal stones by retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) for the treatment of lower calyceal stones between 1 and 2 centimeters (cm) in size.
Read the detailed description
The lifelong prevalence of urinary system stone disease is approximately 15%. The lower calyx is the most common location where renal calculi occur. Because anatomical factors preclude spontaneous passage in this area, the need for treatment is more likely in lower calyceal stones. The European Association of Urology (EAU) suggests percutaneous nephrolithotomy (PNL) for stones larger than 2 centimeters (cm) and shock wave lithotripsy (SWL) or retrograde intrarenal surgery (RIRS) for stones smaller than 1cm as a first option, but controversy continues regarding the best treatment option for medium-sized lower calyceal stones of between 1cm and 2cm.
Medical costs are divided into two components: direct and indirect. Direct costs encompass all medical expenditures (e.g., drugs, hospital bed, all consumable and non-consumable materials used during the operation), while indirect costs include loss of working days for the patient. The stone-free rates (SFR) are reported as approximately 60% and 90% for one session of RIRS and PNL, respectively; however, no physician can guarantee a 100% SFR for one session. For this reason, a full cost analysis must include the direct and indirect costs of both the first and all auxiliary procedures.
The aim of this study was to perform a full cost analysis for the complete clearance of calyceal stones by RIRS and all PNL types for the treatment of lower calyceal stones between 1cm and 2cm in size.
- Conditions
- Renal Calculi
- Being tested
- Retrograde intrarenal surgery, Micro-PNL, Ultra-mini PNL, Mini-PNL, Standard PNL
- Keywords
- Lower calyceal stone, cost-effectiveness, percutaneous nephrolithotomy, retrograde intrarenal surgery
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde intrarenal surgeryProcedure or surgery
The procedure was performed with the patient in the dorsal lithotomy position under general anesthesia. Firstly, diagnostic ureteroscopy was done with a 6/7.5 Fr semi-rigid ureteroscope (Richard Wolf, Knittlingen, Germany). A 0.035mm double-tipped sensor guidewire was placed to the renal pelvis. A 10/12 Fr ureteric access sheath (Cook Medical, Indiana, USA) was used. A 7.5 Fr flexible ureteroscope (Flex X2, Karl Storz, Tuttlingen, Germany) was used for the main procedure. The stones were fragmented using a Holmium:Yttrium Aluminum Garnet laser (272 microns). At the end of each procedure, a double-j ureteric catheter and urethral catheter were routinely placed.
Micro-PNLProcedure or surgery
The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 4.8 Fr for micro PNL (PolyDiagnost, Pfaffenhofen, Germany). Stone fragmentation was carried out using laser in micro PNL. No nephrostomy was placed in any patient whom underwent micro PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.
Ultra-mini PNLProcedure or surgery
The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 7.5 Fr for ultramini PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using laser in ultramini PNL. No nephrostomy was placed in any patient whom underwent ultramini PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.
Mini-PNLProcedure or surgery
The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 12 Fr for mini PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using pneumatic, ultrasonic or laser in mini PNL. No nephrostomy was placed in any patient whom underwent mini PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.
Standard PNLProcedure or surgery
The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 24 Fr for standard PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using pneumatic, ultrasonic or laser in standard PNL. A nephrostomy was placed in all standard PNL patients at the end of the procedure
| Study group | Role | What they receive |
|---|---|---|
| RIRS | Active comparator | Patients underwent retrograde intrarenal surgery for lower calyceal stone between 1cm and 2cm in size Receives: Procedure: Retrograde intrarenal surgery |
| Micro-PNL | Active comparator | Patients underwent micro percutaneous nephrolithotomy (tract size <10 F) for lower calyceal stone between 1cm and 2cm in size Receives: Procedure: Micro-PNL |
| Ultramini-PNL | Active comparator | Patients underwent ultra-mini percutaneous nephrolithotomy (tract size <15 F) for lower calyceal stone between 1cm and 2cm in size Receives: Procedure: Ultra-mini PNL |
| Mini-PNL | Active comparator | Patients underwent mini percutaneous nephrolithotomy (tract size <20 F) for lower calyceal stone between 1cm and 2cm in size Receives: Procedure: Mini-PNL |
| Standard PNL | Active comparator | Patients underwent standard percutaneous nephrolithotomy (tract size >25 F) for lower calyceal stone between 1cm and 2cm in size Receives: Procedure: Standard PNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free status
Stone-free was defined as no rest stone or ≤ 3mm clinical insignificance rest stone
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Jan 2007
- Primary completion1 Jan 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal CalculiStudies 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
- Model description
- Patients who had a lower calyceal stone between 1cm and 2cm in size
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Turkey
- Responsible party
- Principal investigator, Muhammet Fatih Kilinc, Ankara Training and Research Hospital
- Investigators
- Muhammet F Kilinc, M.D., Principal investigator, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614247
- Sponsor's protocol ID
- 2730
- Status last verified
- Jul 2018
- First submitted
- 30 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schoenthaler M, Wilhelm K, Hein S, Adams F, Schlager D, Wetterauer U, Hawizy A, Bourdoumis A, Desai J, Miernik A. Ultra-mini PCNL versus flexible ureteroscopy: a matched analysis of treatment costs (endoscopes and disposables) in patients with renal stones 10-20 mm. World J Urol. 2015 Oct;33(10):1601-5. doi: 10.1007/s00345-015-1489-4. Epub 2015 Jan 23.
PubMed 25614255Sabnis RB, Ganesamoni R, Doshi A, Ganpule AP, Jagtap J, Desai MR. Micropercutaneous nephrolithotomy (microperc) vs retrograde intrarenal surgery for the management of small renal calculi: a randomized controlled trial. BJU Int. 2013 Aug;112(3):355-61. doi: 10.1111/bju.12164.
PubMed 23826843Demirbas A, Resorlu B, Sunay MM, Karakan T, Karagoz MA, Doluoglu OG. Which Should be Preferred for Moderate-Size Kidney Stones? Ultramini Percutaneous Nephrolithotomy or Retrograde Intrarenal Surgery? J Endourol. 2016 Dec;30(12):1285-1289. doi: 10.1089/end.2016.0370.
PubMed 27706948
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones of 1 to 2 Centimeters: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03614247
- Acronym / sponsor ID
- 2730
- Conditions
- Renal Calculi
- Keywords
- Lower calyceal stone, cost-effectiveness, percutaneous nephrolithotomy, retrograde intrarenal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Turkey
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 3 Aug 2018 (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 of the present study to perform a full cost analysis for the complete clearance of calyceal stones by retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) for the treatment of lower calyceal stones between 1 and 2 centimeters (cm) in size.
Detailed description
The lifelong prevalence of urinary system stone disease is approximately 15%. The lower calyx is the most common location where renal calculi occur. Because anatomical factors preclude spontaneous passage in this area, the need for treatment is more likely in lower calyceal stones. The European Association of Urology (EAU) suggests percutaneous nephrolithotomy (PNL) for stones larger than 2 centimeters (cm) and shock wave lithotripsy (SWL) or retrograde intrarenal surgery (RIRS) for stones smaller than 1cm as a first option, but controversy continues regarding the best treatment option for medium-sized lower calyceal stones of between 1cm and 2cm.
Medical costs are divided into two components: direct and indirect. Direct costs encompass all medical expenditures (e.g., drugs, hospital bed, all consumable and non-consumable materials used during the operation), while indirect costs include loss of working days for the patient. The stone-free rates (SFR) are reported as approximately 60% and 90% for one session of RIRS and PNL, respectively; however, no physician can guarantee a 100% SFR for one session. For this reason, a full cost analysis must include the direct and indirect costs of both the first and all auxiliary procedures.
The aim of this study was to perform a full cost analysis for the complete clearance of calyceal stones by RIRS and all PNL types for the treatment of lower calyceal stones between 1cm and 2cm in size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Patients who had a lower calyceal stone between 1cm and 2cm in size
| Arm | Type | Receives |
|---|---|---|
| RIRS | Active comparator | Procedure: Retrograde intrarenal surgeryPatients underwent retrograde intrarenal surgery for lower calyceal stone between 1cm and 2cm in size |
| Micro-PNL | Active comparator | Procedure: Micro-PNLPatients underwent micro percutaneous nephrolithotomy (tract size <10 F) for lower calyceal stone between 1cm and 2cm in size |
| Ultramini-PNL | Active comparator | Procedure: Ultra-mini PNLPatients underwent ultra-mini percutaneous nephrolithotomy (tract size <15 F) for lower calyceal stone between 1cm and 2cm in size |
| Mini-PNL | Active comparator | Procedure: Mini-PNLPatients underwent mini percutaneous nephrolithotomy (tract size <20 F) for lower calyceal stone between 1cm and 2cm in size |
| Standard PNL | Active comparator | Procedure: Standard PNLPatients underwent standard percutaneous nephrolithotomy (tract size >25 F) for lower calyceal stone between 1cm and 2cm in size |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had a lower calyceal stone between 1cm and 2 cm in size
Key exclusion criteria (7 listed)
- solitary or anomaly (horseshoe or pelvic kidney) kidney,
- renal insufficiency,
- pregnancy,
- patient younger than 18 or older than 75 years,
- non-interrupted antithrombotic medication before surgery,
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 |
|---|---|---|
| Retrograde intrarenal surgeryThe procedure was performed with the patient in the dorsal lithotomy position under general anesthesia. Firstly, diagnostic ureteroscopy was done with a 6/7.5 Fr semi-rigid ureteroscope (Richard Wolf, Knittlingen, Germany). A 0.035mm double-tipped sensor guidewire was placed to the renal pelvis. A 10/12 Fr ureteric access sheath (Cook Medical, Indiana, USA) was used. A 7.5 Fr flexible ureteroscope (Flex X2, Karl Storz, Tuttlingen, Germany) was used for the main procedure. The stones were fragmented using a Holmium:Yttrium Aluminum Garnet laser (272 microns). At the end of each procedure, a double-j ureteric catheter and urethral catheter were routinely placed. | Procedure or surgery | RIRS |
| Micro-PNLThe PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 4.8 Fr for micro PNL (PolyDiagnost, Pfaffenhofen, Germany). Stone fragmentation was carried out using laser in micro PNL. No nephrostomy was placed in any patient whom underwent micro PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients. | Procedure or surgery | Micro-PNL |
| Ultra-mini PNLThe PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 7.5 Fr for ultramini PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using laser in ultramini PNL. No nephrostomy was placed in any patient whom underwent ultramini PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients. | Procedure or surgery | Ultramini-PNL |
| Mini-PNLThe PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 12 Fr for mini PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using pneumatic, ultrasonic or laser in mini PNL. No nephrostomy was placed in any patient whom underwent mini PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients. | Procedure or surgery | Mini-PNL |
| Standard PNLThe PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 24 Fr for standard PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using pneumatic, ultrasonic or laser in standard PNL. A nephrostomy was placed in all standard PNL patients at the end of the procedure | Procedure or surgery | Standard PNL |
Primary outcome
Stone free status
Time frame: 3 months
Stone-free was defined as no rest stone or ≤ 3mm clinical insignificance rest stone
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 Aug 2018.
- Results publication: PubMed 25614255Schoenthaler M, Wilhelm K, Hein S, Adams F, Schlager D, Wetterauer U, Hawizy A, Bourdoumis A, Desai J, Miernik A. Ultra-mini PCNL versus flexible ureteroscopy: a matched analysis of treatment costs (endoscopes and disposables) in patients with renal stones 10-20 mm. World J Urol. 2015 Oct;33(10):1601-5. doi: 10.1007/s00345-015-1489-4. Epub 2015 Jan 23.
- Results publication: PubMed 23826843Sabnis RB, Ganesamoni R, Doshi A, Ganpule AP, Jagtap J, Desai MR. Micropercutaneous nephrolithotomy (microperc) vs retrograde intrarenal surgery for the management of small renal calculi: a randomized controlled trial. BJU Int. 2013 Aug;112(3):355-61. doi: 10.1111/bju.12164.
- Results publication: PubMed 27706948Demirbas A, Resorlu B, Sunay MM, Karakan T, Karagoz MA, Doluoglu OG. Which Should be Preferred for Moderate-Size Kidney Stones? Ultramini Percutaneous Nephrolithotomy or Retrograde Intrarenal Surgery? J Endourol. 2016 Dec;30(12):1285-1289. doi: 10.1089/end.2016.0370.
- Individual participant dataSharing planned: Undecided
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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.
Muhammet F Kilinc, M.D. principal investigator
Ankara Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Retrograde intrarenal surgery, Micro-PNL and Ultra-mini PNL in people with Renal Calculi, run by Ankara Training and Research Hospital.
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 7 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 status (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614247, which also lists 3 linked publications.
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 Aug 2018.