Ureteral StonesNCT03559738
ESWL vs URS in Management of Upper Third Ureteric Calculi
An observational study of Ureteral Stones, run by Assiut University.
Trial summary
comparative study of two treatment modalities (ureteroscopy and extracorporeal shock wave lithotripsy) in management of upper third ureteral calculi Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ureteral Stones
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 1 Jun 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 60 cases will be assigned to either ESWL or URS randomly
Who may be able to join
- The study will include patients in the age group of 18-70 years with body mass index of less than or equal to 30 kg/m2 with Upper Ureteral Calculi more than or equal to 1 cm with density about 900 - 1100 HU
Who cannot join
- Patients with distal obstruction
- Impacted stones : An impacted stone is defined as a stone where a guidewire will not pass without ancillary measures and/or a stone that does not move when forceful irrigation is applied ureteroscopically
- Marked hydronephrosis : gross dilation/ballooning of the renal pelvis and calyces with loss of borders between the renal pelvis and calyces and renal atrophy seen as cortical thinning
- Radiolucent stones
- Pregnancy
- Stones in Children
Show all 9Show fewer
- Spinal deformity
- Morbid obesity
- Patients on Aspirin
About this study
Official title: Comparative Study of Extracorporeal Shock Wave Lithotripsy and Ureteroscopy in Management of Upper Third Ureteral Calculi
comparative study of two treatment modalities (ureteroscopy and extracorporeal shock wave lithotripsy) in management of upper third ureteral calculi
Read the detailed description
Large impacted upper ureteral calculus is defined as a stone located above the lower border of the fourth lumbar vertebra, remaining fixed at the same site for at least six weeks. Moreover, it is associated with hydronephrosis and/or prevents contrast medium from passing below the calculus on intravenous urography (IVU).Moreover, there is inability to pass a guidewire or catheter beyond the stone at initial attempts. The treatment for patients with large impacted proximal ureteral stone remains controversial; the surgical options for the treatment of proximal ureteral stones include extracorporeal shockwave lithotripsy (ESWL), Ureteroscopy, PCNL and rarely Laparoscopic or Open surgery. Every technique has its own limitations. The aim of this study is to compare and to evaluate the outcome and complications of two main treatments procedures for impacted proximal ureteral calculi, Extracorporeal Shock Wave Lithotripsy (ESWL) and Ureteroscopy.
Extracorporeal Shock Wave Lithotripsy (ESWL) and Ureteroscopy are two common modalities in the management of Proximal Ureteral Calculi.European Association of Urology (EAU) and American Urological Association (AUA) guidelines have recommended URS or ESWL as first-line treatment Options.ESWL is an effective and non-invasive treatment method in urolithiasis, particularly in stones located in the upper third of the ureters.However, URS is a more invasive technique when compared to ESWL, URS became the most efficient treatment method in proximal ureteral calculi after the development of small-caliber, semi-rigid and flexible endoscopes and the holmium:YAG laser. Today, the greatest dilemma faced by Urologists is to choose between ESWL and URS. A number of factors influence the final results of ESWLand if no fragmentation occurs after several unsuccessful sessions, the stone is considered ESWL-resistant; the case is deemed an ESWL-failure and the patient therefore undergoes URS.URS has been described as a salvage or second line treatment option in cases of ESWL-resistant calculi
- Conditions
- Ureteral Stones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Upper Ureteric Stones | Patients with upper ureteral stones more than 1cm and 1000 HU |
What is being measured
The primary outcome is the main question the study is designed to answer.
identify best management for upper third ureter stones
Matched Pair Analysis of Extracorporeal Shock Wave Lithotripsy versus Ureteroscopy for the management of Upper Ureteral Calculi with relatively small study group by comparing like-for-like Stones
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Jun 2016
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StonesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Atef Abdelaziz Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559738
- Sponsor's protocol ID
- ureteric stones
- Status last verified
- Jun 2018
- First submitted
- 6 Jun 2018
- Last updated
- 18 Jun 2018
- 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 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Extracorporeal Shock Wave Lithotripsy and Ureteroscopy in Management of Upper Third Ureteral Calculi
- ClinicalTrials.gov ID
- NCT03559738
- Acronym / sponsor ID
- ureteric stones
- Conditions
- Ureteral Stones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 18 Jun 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.
comparative study of two treatment modalities (ureteroscopy and extracorporeal shock wave lithotripsy) in management of upper third ureteral calculi
Detailed description
Large impacted upper ureteral calculus is defined as a stone located above the lower border of the fourth lumbar vertebra, remaining fixed at the same site for at least six weeks. Moreover, it is associated with hydronephrosis and/or prevents contrast medium from passing below the calculus on intravenous urography (IVU).Moreover, there is inability to pass a guidewire or catheter beyond the stone at initial attempts. The treatment for patients with large impacted proximal ureteral stone remains controversial; the surgical options for the treatment of proximal ureteral stones include extracorporeal shockwave lithotripsy (ESWL), Ureteroscopy, PCNL and rarely Laparoscopic or Open surgery. Every technique has its own limitations. The aim of this study is to compare and to evaluate the outcome and complications of two main treatments procedures for impacted proximal ureteral calculi, Extracorporeal Shock Wave Lithotripsy (ESWL) and Ureteroscopy.
Extracorporeal Shock Wave Lithotripsy (ESWL) and Ureteroscopy are two common modalities in the management of Proximal Ureteral Calculi.European Association of Urology (EAU) and American Urological Association (AUA) guidelines have recommended URS or ESWL as first-line treatment Options.ESWL is an effective and non-invasive treatment method in urolithiasis, particularly in stones located in the upper third of the ureters.However, URS is a more invasive technique when compared to ESWL, URS became the most efficient treatment method in proximal ureteral calculi after the development of small-caliber, semi-rigid and flexible endoscopes and the holmium:YAG laser. Today, the greatest dilemma faced by Urologists is to choose between ESWL and URS. A number of factors influence the final results of ESWLand if no fragmentation occurs after several unsuccessful sessions, the stone is considered ESWL-resistant; the case is deemed an ESWL-failure and the patient therefore undergoes URS.URS has been described as a salvage or second line treatment option in cases of ESWL-resistant calculi
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Upper Ureteric Stones | – | –Patients with upper ureteral stones more than 1cm and 1000 HU |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 60 cases will be assigned to either ESWL or URS randomly
Key inclusion criteria (1 listed)
- The study will include patients in the age group of 18-70 years with body mass index of less than or equal to 30 kg/m2 with Upper Ureteral Calculi more than or equal to 1 cm with density about 900 - 1100 HU
Key exclusion criteria (9 listed)
- Patients with distal obstruction
- Impacted stones : An impacted stone is defined as a stone where a guidewire will not pass without ancillary measures and/or a stone that does not move when forceful irrigation is applied ureteroscopically
- Marked hydronephrosis : gross dilation/ballooning of the renal pelvis and calyces with loss of borders between the renal pelvis and calyces and renal atrophy seen as cortical thinning
- Radiolucent stones
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
identify best management for upper third ureter stones
Time frame: 2 years
Matched Pair Analysis of Extracorporeal Shock Wave Lithotripsy versus Ureteroscopy for the management of Upper Ureteral Calculi with relatively small study group by comparing like-for-like Stones
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 18 Jun 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteral Stones, run by Assiut University.
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 9 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 18 Jun 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?
identify best management for upper third ureter stones (time frame: 2 years). 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 18 Jun 2018.