UreterolithiasisNCT04894058
Ureteroscopic Lithotripsy in the Reverse Trendelenburg Position for Upper Ureteral Stones
A study testing Ureteroscopic lithotripsy in people with Ureterolithiasis and Ureter Stone, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study investigated a previously unassessed operating position for ureteroscopic holmium laser lithotripsy in patients with upper ureteral stone. The reverse Trendelenburg position can reduce migration and improve the stone free rate (SFR). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ureterolithiasis, Ureter Stone, Ureter Calculi
- What is being tested?
- Ureteroscopic lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Apr 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obstructive upper ureteral stones
Who cannot join
- Presence of stent in the ureter at the beginning of the operation
- Serum creatinine value> 1.5 mg / dL
- Pathological ureteral strictures
- Previous open surgery history for the ureteral stone
- Previous pelvic radiotherapy history
- Pregnancy
- Solitary kidney
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Altindag, 06230
About this study
Official title: Ureteroscopic Lithotripsy in the Reverse Trendelenburg Position for Upper Ureteral Stones: a Prospective, Randomized, Comparative Study
This study investigated a previously unassessed operating position for ureteroscopic holmium laser lithotripsy in patients with upper ureteral stone. The reverse Trendelenburg position can reduce migration and improve the stone free rate (SFR). Moreover, less utilization of flexible ureteroscope and hospital stay in reverse Trendelenburg position can reduce the medical cost. Therefore, it can be safely used as an optional surgical method for the treatment of upper ureteral stones.
Read the detailed description
With the rapid development of urological endoscopy technology, minimally invasive surgery has replaced open surgery in ureteral stones. The majority of upper ureteral stones are treated with endoscopic techniques. In the last 10 years, URSL (Ureteroscopic Lithotripsy) has surpassed SWL (Shock-wave lithotripsy) with its wide use [1]. While URSL was considered in the foreground according to SWL for proximal ureteral stones larger than 1 cm, today it is recommended with equal efficiency and safety with SWL for stones smaller than 1 cm [2]. However, migration of stones to renal calyces is a common problem during ureteroscopic treatment of upper ureteral stones. Migration can be caused by many factors such as the momentum of the laser pulse, stone manipulation of the laser fiber, fluid irrigation pressure and the increase of ureteral dilatation. The degree of migration varies according to the impaction level of the stone and the location in the ureter [3].
The migration of the stone to the renal pelvis and calyces increases the operation time and cost [4-6]. Recently published American Urological Association Guidelines reported that ureteroscopy of ureteral stones performed an average of 1.33 procedures per patient [7]. In order to prevent stone migration, tools have been developed that are used in the proximal of the stone or that interfere with the stone in the kidney after retreatment. Although these developed devices are effective, it has been determined that their additional use causes an additional cost of $ 278 per case as well as extending the operation time [8]. In addition, placing an anti-migration device in the ureter can restrict laser fiber manipulation. Ureterorenoscopes (Flexible URS) that can flex 270 degrees, which can be used to intervene in the stone after retraction into the kidney, have made a very serious improvement, but these devices are not yet available in all centers, especially in developing countries.
There is an in-vitro study using polymer tubes that predict that the proximal ureter should stay higher than the distal ureter in order to prevent retrograde in proximal ureteral stones [9].
- Conditions
- Ureterolithiasis, Ureter Stone, Ureter Calculi
- Being tested
- Ureteroscopic lithotripsy
- Keywords
- Upper ureteral stone, Ureteroscopic lithotripsy, Reverse Trendelenburg
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteroscopic lithotripsyProcedure or surgery
After combined spinal and epidural anesthesia, patients were subjected to low pressure perfusion; The semirigid ureteroscope was passed through the urethra to the bladder, after which both ureteral orifices were observed. A 0.035 "soft-tipped guidewire was sent through the ureter orifice and reached the renal pelvis. Subsequently, the patients were placed in the reverse trendelenburg position by leaning 10 ° or 20 ° with their head up and hips down or standard lithotomy position. The ureter stone was accessed with a semirigid ureteroscope. A 273 micron Holmium: yttrium-aluminum-garnet (Ho: YAG) laser was applied as an energy source set at 1.0 J and a speed of 8-10 Hz.
| Study group | Role | What they receive |
|---|---|---|
| 10 ° reverse Trendelenburg | Active comparator | Patients who underwent ureteroscopic lithotripsy in the 10 ° reverse Trendelenburg position Receives: Procedure: Ureteroscopic lithotripsy |
| 20 ° reverse Trendelenburg | Active comparator | Patients who underwent ureteroscopic lithotripsy in the 20 ° reverse Trendelenburg position Receives: Procedure: Ureteroscopic lithotripsy |
| Standard lithotomy | Sham comparator | Patients who underwent ureteroscopic lithotripsy in standard lithotomy position Receives: Procedure: Ureteroscopic lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of stone migration
Rate of patients who had a stone migration to renal pelvis or calyces during the operation
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Apr 2019
- Primary completion1 Dec 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for UreterolithiasisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaan Yildiz, Ankara Training and Research Hospital
- Investigators
- Ali Kaan Yildiz, Principal investigator, Ankara Training and Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894058
- Sponsor's protocol ID
- RT2021
- Status last verified
- May 2021
- First submitted
- 16 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santiago JE, Hollander AB, Soni SD, Link RE, Mayer WA. To Dust or Not To Dust: a Systematic Review of Ureteroscopic Laser Lithotripsy Techniques. Curr Urol Rep. 2017 Apr;18(4):32. doi: 10.1007/s11934-017-0677-8.
PubMed 28271355Drake T, Grivas N, Dabestani S, Knoll T, Lam T, Maclennan S, Petrik A, Skolarikos A, Straub M, Tuerk C, Yuan CY, Sarica K. What are the Benefits and Harms of Ureteroscopy Compared with Shock-wave Lithotripsy in the Treatment of Upper Ureteral Stones? A Systematic Review. Eur Urol. 2017 Nov;72(5):772-786. doi: 10.1016/j.eururo.2017.04.016. Epub 2017 Apr 26.
PubMed 28456350Elashry OM, Tawfik AM. Preventing stone retropulsion during intracorporeal lithotripsy. Nat Rev Urol. 2012 Dec;9(12):691-8. doi: 10.1038/nrurol.2012.204. Epub 2012 Nov 20.
PubMed 23165399Cicerello E, Merlo F, Maccatrozzo L. Management of Clinically Insignificant Residual Fragments following Shock Wave Lithotripsy. Adv Urol. 2012;2012:320104. doi: 10.1155/2012/320104. Epub 2012 May 31.
PubMed 22701479Sea J, Jonat LM, Chew BH, Qiu J, Wang B, Hoopman J, Milner T, Teichman JM. Optimal power settings for Holmium:YAG lithotripsy. J Urol. 2012 Mar;187(3):914-9. doi: 10.1016/j.juro.2011.10.147. Epub 2012 Jan 20.
PubMed 22264464Pan J, Chen Q, Xue W, Chen Y, Xia L, Chen H, Huang Y. RIRS versus mPCNL for single renal stone of 2-3 cm: clinical outcome and cost-effective analysis in Chinese medical setting. Urolithiasis. 2013 Feb;41(1):73-8. doi: 10.1007/s00240-012-0533-8. Epub 2012 Dec 23.
PubMed 23532427Segura JW, Preminger GM, Assimos DG, Dretler SP, Kahn RI, Lingeman JE, Macaluso JN Jr. Ureteral Stones Clinical Guidelines Panel summary report on the management of ureteral calculi. The American Urological Association. J Urol. 1997 Nov;158(5):1915-21. doi: 10.1016/s0022-5347(01)64173-9.
PubMed 9334635Ursiny M, Eisner BH. Cost-effectiveness of anti-retropulsion devices for ureteroscopic lithotripsy. J Urol. 2013 May;189(5):1762-6. doi: 10.1016/j.juro.2012.11.085. Epub 2012 Nov 15.
PubMed 23159589Patel RM, Walia AS, Grohs E, Okhunov Z, Landman J, Clayman RV. Effect of positioning on ureteric stone retropulsion: 'gravity works'. BJU Int. 2019 Jan;123(1):113-117. doi: 10.1111/bju.14510. Epub 2018 Sep 9.
PubMed 30098120Yildiz AK, Doluoglu OG, Kacan T, Keseroglu BB, Ozgur BC, Karakan T. A new position utilizing the effect of gravity in proximal ureteral stones, ureteroscopic lithotripsy in the reverse Trendelenburg position: a prospective, randomized, comparative study. World J Urol. 2023 Dec;41(12):3695-3703. doi: 10.1007/s00345-023-04654-y. Epub 2023 Oct 19.
PubMed 37855898
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteroscopic Lithotripsy in the Reverse Trendelenburg Position for Upper Ureteral Stones: a Prospective, Randomized, Comparative Study
- ClinicalTrials.gov ID
- NCT04894058
- Acronym / sponsor ID
- RT2021
- Conditions
- Ureterolithiasis, Ureter Stone, Ureter Calculi
- Keywords
- Upper ureteral stone, Ureteroscopic lithotripsy, Reverse Trendelenburg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 20 May 2021 (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.
This study investigated a previously unassessed operating position for ureteroscopic holmium laser lithotripsy in patients with upper ureteral stone. The reverse Trendelenburg position can reduce migration and improve the stone free rate (SFR). Moreover, less utilization of flexible ureteroscope and hospital stay in reverse Trendelenburg position can reduce the medical cost. Therefore, it can be safely used as an optional surgical method for the treatment of upper ureteral stones.
Detailed description
With the rapid development of urological endoscopy technology, minimally invasive surgery has replaced open surgery in ureteral stones. The majority of upper ureteral stones are treated with endoscopic techniques. In the last 10 years, URSL (Ureteroscopic Lithotripsy) has surpassed SWL (Shock-wave lithotripsy) with its wide use [1]. While URSL was considered in the foreground according to SWL for proximal ureteral stones larger than 1 cm, today it is recommended with equal efficiency and safety with SWL for stones smaller than 1 cm [2]. However, migration of stones to renal calyces is a common problem during ureteroscopic treatment of upper ureteral stones. Migration can be caused by many factors such as the momentum of the laser pulse, stone manipulation of the laser fiber, fluid irrigation pressure and the increase of ureteral dilatation. The degree of migration varies according to the impaction level of the stone and the location in the ureter [3].
The migration of the stone to the renal pelvis and calyces increases the operation time and cost [4-6]. Recently published American Urological Association Guidelines reported that ureteroscopy of ureteral stones performed an average of 1.33 procedures per patient [7]. In order to prevent stone migration, tools have been developed that are used in the proximal of the stone or that interfere with the stone in the kidney after retreatment. Although these developed devices are effective, it has been determined that their additional use causes an additional cost of $ 278 per case as well as extending the operation time [8]. In addition, placing an anti-migration device in the ureter can restrict laser fiber manipulation. Ureterorenoscopes (Flexible URS) that can flex 270 degrees, which can be used to intervene in the stone after retraction into the kidney, have made a very serious improvement, but these devices are not yet available in all centers, especially in developing countries.
There is an in-vitro study using polymer tubes that predict that the proximal ureter should stay higher than the distal ureter in order to prevent retrograde in proximal ureteral stones [9].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 ° reverse Trendelenburg | Active comparator | Procedure: Ureteroscopic lithotripsyPatients who underwent ureteroscopic lithotripsy in the 10 ° reverse Trendelenburg position |
| 20 ° reverse Trendelenburg | Active comparator | Procedure: Ureteroscopic lithotripsyPatients who underwent ureteroscopic lithotripsy in the 20 ° reverse Trendelenburg position |
| Standard lithotomy | Sham comparator | Procedure: Ureteroscopic lithotripsyPatients who underwent ureteroscopic lithotripsy in standard lithotomy position |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obstructive upper ureteral stones
Key exclusion criteria (7 listed)
- Presence of stent in the ureter at the beginning of the operation
- Serum creatinine value> 1.5 mg / dL
- Pathological ureteral strictures
- Previous open surgery history for the ureteral stone
- Previous pelvic radiotherapy 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 |
|---|---|---|
| Ureteroscopic lithotripsyAfter combined spinal and epidural anesthesia, patients were subjected to low pressure perfusion; The semirigid ureteroscope was passed through the urethra to the bladder, after which both ureteral orifices were observed. A 0.035 "soft-tipped guidewire was sent through the ureter orifice and reached the renal pelvis. Subsequently, the patients were placed in the reverse trendelenburg position by leaning 10 ° or 20 ° with their head up and hips down or standard lithotomy position. The ureter stone was accessed with a semirigid ureteroscope. A 273 micron Holmium: yttrium-aluminum-garnet (Ho: YAG) laser was applied as an energy source set at 1.0 J and a speed of 8-10 Hz. | Procedure or surgery | 10 ° reverse Trendelenburg, 20 ° reverse Trendelenburg, Standard lithotomy |
Primary outcome
Rate of stone migration
Time frame: One year
Rate of patients who had a stone migration to renal pelvis or calyces during the operation
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 25 May 2021.
- Background: PubMed 28271355Santiago JE, Hollander AB, Soni SD, Link RE, Mayer WA. To Dust or Not To Dust: a Systematic Review of Ureteroscopic Laser Lithotripsy Techniques. Curr Urol Rep. 2017 Apr;18(4):32. doi: 10.1007/s11934-017-0677-8.
- Background: PubMed 28456350Drake T, Grivas N, Dabestani S, Knoll T, Lam T, Maclennan S, Petrik A, Skolarikos A, Straub M, Tuerk C, Yuan CY, Sarica K. What are the Benefits and Harms of Ureteroscopy Compared with Shock-wave Lithotripsy in the Treatment of Upper Ureteral Stones? A Systematic Review. Eur Urol. 2017 Nov;72(5):772-786. doi: 10.1016/j.eururo.2017.04.016. Epub 2017 Apr 26.
- Background: PubMed 23165399Elashry OM, Tawfik AM. Preventing stone retropulsion during intracorporeal lithotripsy. Nat Rev Urol. 2012 Dec;9(12):691-8. doi: 10.1038/nrurol.2012.204. Epub 2012 Nov 20.
- Background: PubMed 22701479Cicerello E, Merlo F, Maccatrozzo L. Management of Clinically Insignificant Residual Fragments following Shock Wave Lithotripsy. Adv Urol. 2012;2012:320104. doi: 10.1155/2012/320104. Epub 2012 May 31.
- Background: PubMed 22264464Sea J, Jonat LM, Chew BH, Qiu J, Wang B, Hoopman J, Milner T, Teichman JM. Optimal power settings for Holmium:YAG lithotripsy. J Urol. 2012 Mar;187(3):914-9. doi: 10.1016/j.juro.2011.10.147. Epub 2012 Jan 20.
- Background: PubMed 23532427Pan J, Chen Q, Xue W, Chen Y, Xia L, Chen H, Huang Y. RIRS versus mPCNL for single renal stone of 2-3 cm: clinical outcome and cost-effective analysis in Chinese medical setting. Urolithiasis. 2013 Feb;41(1):73-8. doi: 10.1007/s00240-012-0533-8. Epub 2012 Dec 23.
- Background: PubMed 9334635Segura JW, Preminger GM, Assimos DG, Dretler SP, Kahn RI, Lingeman JE, Macaluso JN Jr. Ureteral Stones Clinical Guidelines Panel summary report on the management of ureteral calculi. The American Urological Association. J Urol. 1997 Nov;158(5):1915-21. doi: 10.1016/s0022-5347(01)64173-9.
- Background: PubMed 23159589Ursiny M, Eisner BH. Cost-effectiveness of anti-retropulsion devices for ureteroscopic lithotripsy. J Urol. 2013 May;189(5):1762-6. doi: 10.1016/j.juro.2012.11.085. Epub 2012 Nov 15.
- Background: PubMed 30098120Patel RM, Walia AS, Grohs E, Okhunov Z, Landman J, Clayman RV. Effect of positioning on ureteric stone retropulsion: 'gravity works'. BJU Int. 2019 Jan;123(1):113-117. doi: 10.1111/bju.14510. Epub 2018 Sep 9.
- Derived from this study: PubMed 37855898Yildiz AK, Doluoglu OG, Kacan T, Keseroglu BB, Ozgur BC, Karakan T. A new position utilizing the effect of gravity in proximal ureteral stones, ureteroscopic lithotripsy in the reverse Trendelenburg position: a prospective, randomized, comparative study. World J Urol. 2023 Dec;41(12):3695-3703. doi: 10.1007/s00345-023-04654-y. Epub 2023 Oct 19.
- Individual participant dataSharing planned: No
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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.
Ali Kaan Yildiz principal investigator
Ankara Training and Resarch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteroscopic lithotripsy in people with Ureterolithiasis and Ureter Stone, run by Ankara Training and Research 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 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 25 May 2021. 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. Some participants in this study may receive a placebo. 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?
Rate of stone migration (time frame: One year). 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 NCT04894058, which also lists 10 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 25 May 2021.