UrolithiasisNCT03636516
Effect of Double J Stent on Outcomes of Extracorporeal Shock Wave Lithotripsy
A study testing SWL in people with Urolithiasis, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital.
Trial summary
Background: Many studies showed that stone-free rates (SFRs) after extracorporeal shock wave lithotripsy (SWL) might be related to both the patient (body mass index; BMI, skin-to-stone distance; SSD), and stone related factors (location, stone size, and stone density). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis
- What is being tested?
- SWL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Dec 2017
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with solitary kidneys, congenital abnormalities, skeletal system abnormalities, previous urinary system surgery, HN (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded from the study.
About this study
Official title: Effect of Double J Stent on Outcomes of Extracorporeal Shock Wave Lithotripsy Treatment of Moderate Sized Renal Pelvic Stones: A Randomized Prospective Study
Background: Many studies showed that stone-free rates (SFRs) after extracorporeal shock wave lithotripsy (SWL) might be related to both the patient (body mass index; BMI, skin-to-stone distance; SSD), and stone related factors (location, stone size, and stone density). However, the possible effect of pre-stenting on success as well as complication rates after SWL has not been evaluated in detail to date. Taking this fact into account, the effect of pre-stenting on the outcomes of SWL treatment in renal stones must be evaluated in the absence of possible effects induced by the patient and stone-related factors. Aim: To evaluate the effect of double J (JJ) stents on SWL treatment of moderate sized (15-25-mm) renal pelvic stones. Study design: Randomized prospective study Methods: Between January 2016 and December 2017, a total of 152 adult patients who were planned to undergo SWL for a single radiopaque renal pelvic stone were included in the study. Patients with solitary kidney, congenital abnormality, skeletal tract abnormalities, previous urinary system surgery, hydronephrosis (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded. The remaining 114 patients were randomly divided into two groups; nonstented and stented. Twenty-two patients whose stone could not be fragmented despite 3 consecutive sessions were also excluded from the study. A total of 92 patients (54 non-stented and 38 stented) were included in the final analysis.
Read the detailed description
Study design Between January 2016 and December 2017, a total of 152 adult (age > 18 years) patients who were planned to undergo extracorporeal shock wave lithotripsy (SWL) for a single radiopaque renal pelvic stone with a largest diameter of 15 to 25 mm were included in the study. Patients with solitary kidneys, congenital abnormalities, skeletal system abnormalities, previous urinary system surgery, hydronephrosis (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded from the study. The remaining 114 patients were randomly divided into two groups as non-stented (n=67) and stented (n=47). Randomization was performed by flipping a coin. During SWL procedures, 22 patients whose stone could not be fragmented despite 3 consecutive sessions were also excluded from the study. A total of 92 patients (54 non-stented and 38 stented) were included in the final analysis.
Preprocedural evaluation All patients were evaluated preoperatively using non-contrast computed tomography (CT). Prior to treatment, a complete urine test, if needed urine culture and antibiogram test, simple serum biochemistry and coagulation tests were performed in all patients. The impact of patient-related factors (age, sex, body mass index;BMI), stone-related factors (laterality, stone size and Hounsfield units; HU), renal parenchymal thickness (RPT), and skin-to-stone distance (SSD) on fragmentation were analyzed. Body mass index (BMI) was calculated by dividing the weight (kg) by the square of the height (m2). CT with 5-mm contiguous sections at 120 kw and 90 milliampere (mA) was performed in all patients using a multidetector row helical CT scanner (Somatom Plus; Siemens, Germany). The longitudinal stone dimension was calculated by multiplying collimation thickness and the number of images in which the stone seen. The transverse dimension was chosen as the diameter of stone from the image showing its largest width. The maximum dimension of the stone was accepted as the highest value measured, either the longitudinal or transverse diameter. The average CT attenuation value as the representative HU was measured by drawing a region of interest smaller than the stone in the image showing the stone in the largest dimension. The SSD was calculated by measuring the distance from the skin to the stone at posterolateral 45°. All patients signed an informed consent form for SWL and pre-stenting. Stent size was 4.8 French and 26 cm.
SWL technique SWL was performed with an electromagnetic lithotripter Compact Sigma (Dornier Med Tech System Gesellschaft mit beschränkter Haftung; GmbH, Weßling, Germany) by the same operator, with the patient in the supine position, and with a standardized treatment angle under both fluoroscopic and ultrasonic guidance. SWL procedures were performed with analgesic application (75 mg diclofenac sodium). If needed, a compression bag was used to decrease stone movement caused by respiration. Each session was completed either after application of a total of 3000 shock waves or when the stone was completely disintegrated. The degree of shock wave power delivered during SWL was recorded as 1 to 6 and the shock wave frequency was 90/minute. Individual power settings were adjusted according to the patient's tolerance. Patients were evaluated 1 week after each session through abdominal kidneys, ureters, and urinary bladder (KUB) X-ray and repeat treatment was performed in cases of inadequate disintegration. Management was stopped when there was no disintegration despite 3 SWL sessions. No patients received medical expulsive treatment (MET) before or after SWL sessions. JJ stents were removed after 4 weeks. In view of the radiographic assessment with CT performed 4 months following the last SWL session, treatment results were categorized as either successful or unsuccessful according to whether there were any residual stone fragments. During SWL sessions and after treatment, the number of emergency department visits and analgesic consumption were recorded.
Statistical analysis Data were analyzed using the Statistical Package for the Social Sciences software version 19 (SPSS Inc., Chicago, Illinois, USA). Descriptive statistics were determined for the mean, standard deviation, lowest and highest, and ratio values. The distribution of the variables was measured using the Kolmogorov-Smirnov test. Univariate (Chi-square or t-test) tests were performed to determine whether there was a statistically significant difference for characteristics between the stented and non-stented groups. If parameters did not show normal dispersion, the Mann-Whitney U test, which is the nonparametric equivalent of the t-test, was performed. The threshold for statistical significance was accepted as p < 0.05 for all analyses.
- Conditions
- Urolithiasis
- Being tested
- SWL
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWLDevice
extracorporeal shockwave lithotripsy apply
| Study group | Role | What they receive |
|---|---|---|
| jj stent yes | Active comparator | Not described Receives: Device: SWL |
| jj stent no | Active comparator | Not described Receives: Device: SWL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients, who have JJ stent or not, with successful SWL treatment.
Number of patients, who have JJ stent or not, with successful SWL treatment which assessed after 3 months following the last SWL session.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Jan 2016
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Akif Erbin, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636516
- Sponsor's protocol ID
- 123456789
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- 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 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Double J Stent on Outcomes of Extracorporeal Shock Wave Lithotripsy Treatment of Moderate Sized Renal Pelvic Stones: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT03636516
- Acronym / sponsor ID
- 123456789
- Conditions
- Urolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 17 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.
Background: Many studies showed that stone-free rates (SFRs) after extracorporeal shock wave lithotripsy (SWL) might be related to both the patient (body mass index; BMI, skin-to-stone distance; SSD), and stone related factors (location, stone size, and stone density). However, the possible effect of pre-stenting on success as well as complication rates after SWL has not been evaluated in detail to date. Taking this fact into account, the effect of pre-stenting on the outcomes of SWL treatment in renal stones must be evaluated in the absence of possible effects induced by the patient and stone-related factors. Aim: To evaluate the effect of double J (JJ) stents on SWL treatment of moderate sized (15-25-mm) renal pelvic stones. Study design: Randomized prospective study Methods: Between January 2016 and December 2017, a total of 152 adult patients who were planned to undergo SWL for a single radiopaque renal pelvic stone were included in the study. Patients with solitary kidney, congenital abnormality, skeletal tract abnormalities, previous urinary system surgery, hydronephrosis (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded. The remaining 114 patients were randomly divided into two groups; nonstented and stented. Twenty-two patients whose stone could not be fragmented despite 3 consecutive sessions were also excluded from the study. A total of 92 patients (54 non-stented and 38 stented) were included in the final analysis.
Detailed description
Study design Between January 2016 and December 2017, a total of 152 adult (age > 18 years) patients who were planned to undergo extracorporeal shock wave lithotripsy (SWL) for a single radiopaque renal pelvic stone with a largest diameter of 15 to 25 mm were included in the study. Patients with solitary kidneys, congenital abnormalities, skeletal system abnormalities, previous urinary system surgery, hydronephrosis (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded from the study. The remaining 114 patients were randomly divided into two groups as non-stented (n=67) and stented (n=47). Randomization was performed by flipping a coin. During SWL procedures, 22 patients whose stone could not be fragmented despite 3 consecutive sessions were also excluded from the study. A total of 92 patients (54 non-stented and 38 stented) were included in the final analysis.
Preprocedural evaluation All patients were evaluated preoperatively using non-contrast computed tomography (CT). Prior to treatment, a complete urine test, if needed urine culture and antibiogram test, simple serum biochemistry and coagulation tests were performed in all patients. The impact of patient-related factors (age, sex, body mass index;BMI), stone-related factors (laterality, stone size and Hounsfield units; HU), renal parenchymal thickness (RPT), and skin-to-stone distance (SSD) on fragmentation were analyzed. Body mass index (BMI) was calculated by dividing the weight (kg) by the square of the height (m2). CT with 5-mm contiguous sections at 120 kw and 90 milliampere (mA) was performed in all patients using a multidetector row helical CT scanner (Somatom Plus; Siemens, Germany). The longitudinal stone dimension was calculated by multiplying collimation thickness and the number of images in which the stone seen. The transverse dimension was chosen as the diameter of stone from the image showing its largest width. The maximum dimension of the stone was accepted as the highest value measured, either the longitudinal or transverse diameter. The average CT attenuation value as the representative HU was measured by drawing a region of interest smaller than the stone in the image showing the stone in the largest dimension. The SSD was calculated by measuring the distance from the skin to the stone at posterolateral 45°. All patients signed an informed consent form for SWL and pre-stenting. Stent size was 4.8 French and 26 cm.
SWL technique SWL was performed with an electromagnetic lithotripter Compact Sigma (Dornier Med Tech System Gesellschaft mit beschränkter Haftung; GmbH, Weßling, Germany) by the same operator, with the patient in the supine position, and with a standardized treatment angle under both fluoroscopic and ultrasonic guidance. SWL procedures were performed with analgesic application (75 mg diclofenac sodium). If needed, a compression bag was used to decrease stone movement caused by respiration. Each session was completed either after application of a total of 3000 shock waves or when the stone was completely disintegrated. The degree of shock wave power delivered during SWL was recorded as 1 to 6 and the shock wave frequency was 90/minute. Individual power settings were adjusted according to the patient's tolerance. Patients were evaluated 1 week after each session through abdominal kidneys, ureters, and urinary bladder (KUB) X-ray and repeat treatment was performed in cases of inadequate disintegration. Management was stopped when there was no disintegration despite 3 SWL sessions. No patients received medical expulsive treatment (MET) before or after SWL sessions. JJ stents were removed after 4 weeks. In view of the radiographic assessment with CT performed 4 months following the last SWL session, treatment results were categorized as either successful or unsuccessful according to whether there were any residual stone fragments. During SWL sessions and after treatment, the number of emergency department visits and analgesic consumption were recorded.
Statistical analysis Data were analyzed using the Statistical Package for the Social Sciences software version 19 (SPSS Inc., Chicago, Illinois, USA). Descriptive statistics were determined for the mean, standard deviation, lowest and highest, and ratio values. The distribution of the variables was measured using the Kolmogorov-Smirnov test. Univariate (Chi-square or t-test) tests were performed to determine whether there was a statistically significant difference for characteristics between the stented and non-stented groups. If parameters did not show normal dispersion, the Mann-Whitney U test, which is the nonparametric equivalent of the t-test, was performed. The threshold for statistical significance was accepted as p < 0.05 for all analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| jj stent yes | Active comparator | Device: SWL |
| jj stent no | Active comparator | Device: SWL |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients with solitary kidneys, congenital abnormalities, skeletal system abnormalities, previous urinary system surgery, HN (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded from the study.
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 |
|---|---|---|
| SWLextracorporeal shockwave lithotripsy apply | Device | jj stent no, jj stent yes |
Primary outcome
Number of patients, who have JJ stent or not, with successful SWL treatment.
Time frame: 15 weeks
Number of patients, who have JJ stent or not, with successful SWL treatment which assessed after 3 months following the last SWL session.
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 17 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Urolithiasis
Enrolling by invitationObservational study
Renal Structural and Functional Alterations Following Repeated Ureteroscopic Procedures: An Exploratory Multimodal Imaging Study
Urolithiasis, Intrarenal Pressure
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Recruiting
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Urolithiasis, Stones, Kidney
Active, not recruitingObservational study
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Urolithiasis, Kidney Stone
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.
Questions about this trial
What is this clinical trial studying?
A study testing SWL in people with Urolithiasis, run by Dr. Lutfi Kirdar Kartal 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 0 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 17 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?
Number of patients, who have JJ stent or not, with successful SWL treatment. (time frame: 15 weeks). 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 17 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.