UrolithiasisNCT03717285
Under Direct Vision vs Under Non Direct Vision of Insertion of UAS in RIRS
A study testing Insert the UAS under direct vision and Insert the UAS under non direct vision in people with Urolithiasis, run by Guohua Zeng at 1 site in China.
Trial summary
Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Insert the UAS under direct vision and Insert the UAS under non direct vision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2018to 31 Dec 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be a suitable operative candidate for RIRS
- Age 18 to 70 years
- Normal renal function 4 .ASA score Ⅰ and Ⅱ
- 5. Single renal stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm
Who cannot join
- Patients with solitary kidney
- Uncorrected coagulopathy and active urinary tract infection (UTI)
- Prior ipsilateral endourological procedure history, such as RIRS, PCNL, URS and URL
- Patients who underwent transplant or urinary diversion.
- Congenital abnormalities.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
Guohua Zeng, Ph.D and M.D, +86 13802916676, gzgyzgh@vip.tom.com
About this study
Official title: Under Direct Vision Versus Under Non Direct Vision for The Efficacy and Safety Ureteral Access Sheath in RIRS for the Management of ≤20mm Size Kidney Stones: A Single-center Randomized Controlled Trial
Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious complications. In long-term clinical practice， the investigators has found that many ureteral injuries occur during UAS insertion of the ureter from ureteral orifice. And if we use rigid ureteroscopy to insert the UAS under direct vision, we can provide the placement success rate and reduce the incidence of complications. The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of under direct vision and under non direct vision during the insertion of UAS.
Read the detailed description
Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious complications. In long-term clinical practice， the investigators has found that many ureteral injuries occur during UAS insertion of the ureter from ureteral orifice. And if we use rigid ureteroscopy to insert the UAS under direct vision, we can provide the UAS insertion success rate and reduce the incidence of complications.
Options for the UAS insertion include inserted under fluoroscopy control or inserted by the experience of the surgeon. The former is more commonly used in the United States, while the latter is more commonly used in China. But neither is perfect. Moreover, Ibrahim Karabulut et al. and Mehmet Giray Sönmez et al. reported a different technique for placement ureteral access sheath called "Endovisional technique" in which the outer sheath of UAS was worn on the semirigid endoscope and placed into the ureter under direct vision. Nevertheless, They found that complication rate was lower in the patients who had the UAS placed under "Endovisional technique" when compared to the classical technique. But the difference was not statistically significant. In addition, the investigators are concerned that failure to use sheath cores may cause new damage to the ureter.
So the investigators find a new way to insert UAS without damaging the ureter. In our new procedure, the patient is placed in the lithotomy position, and a 0.035'' flexible tip guidewire is placed into the renal pelvis using a ureteroscope. Then take out the ureteroscope and insert the ureteroscope into urinary bladder beside the guidewire. A 12 Fr/ 14 Fr ureteral access sheath (UAS) is advanced into the ureteral over the guidewire under direct vision. When the UAS successfully enters the ureteral orifice a few centimeters, the ureteroscope is removed. Continue inserting the UAS into the proximal ureter or UPJ and use the direct urinary system X-graphy (DUSG) to confirm that the UAS is inserted into the correct position. A P5 or P6 Olympus flexible ureteroscope is passed through the UAS to finish lithotripsy.
Until now, routine technique to insert ureteral access sheath during RIRS is still under discussion. The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of under direct vision and under non direct vision during the insertion of UAS.
- Conditions
- Urolithiasis
- Being tested
- Insert the UAS under direct vision, Insert the UAS under non direct vision
- Keywords
- RIRS, Renal stones, ureteral access sheath, ureteral injury
- Medical subject headings
- Urolithiasis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insert the UAS under direct visionProcedure or surgery
Patients in this group，we use rigid ureteroscopy to insert the UAS under direct vision.
Insert the UAS under non direct visionProcedure or surgery
Patients in this group，we insert the UAS by the experience of the surgeon and under non direct vision .
| Study group | Role | What they receive |
|---|---|---|
| Group 1:Under direct vision | Experimental | Patients in Group 1 insert the UAS under direct vision.In this procedure,the investigators will insert the ureteroscope into urinary bladder beside the guidewire to observe the process of uas insertion into the ureter. Receives: Procedure: Insert the UAS under direct vision |
| Group 2:Under non direct vision | Active comparator | Patients in Group 2 insert the UAS under non direct vision.In this procedure,the investigators will insert the UAS under fluoroscopy control. Receives: Procedure: Insert the UAS under non direct vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
UAS insertion success rate
Primary insertion of a UAS is not always possible. The ideal position of the UAS is with its distal extremity just below the ureteric-pelvic junction (UPJ). Insertion failure is defined as UAS cross the upj or do not reach the proximal ureter or the surgeon's decision to resign UAS insertion due to high resistance to the retrograde progression of the UAS along the urinary tract.
Measured: intraoperatively
Secondary outcomes (2)
Complication rate
Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on.The investigator will invaluate perioperative complications by modified Clavien system
Measured: 1 month after removing the pigtail stent
Ureteral lesion grade
Base on post-ureteroscopic lesion scale (PULS), reported byTraxer O and Thomas A in 2013.UAS related ureteral injuries were divided into 5 grades according to ureteral wall anatomy.Grade 0 means no lesion found or only mucosal petechiae. Grade 1 means ureteral mucosal erosion without smooth muscle injury. Both Grade 0 and Grade 1 are considered as low-level injuries. Grade 2 means ureteral wall injury, including mucosa and smooth muscle, with adventitial preservation (periureteral fat not seen). Grade 3 means ureteral injury indicated ureteral perforation involving the full thickness of the ureteral wall, including the adventitia.Grade 4 means injury corresponded to total ureteral avulsion with complete rupture of ureteral continuity. Grade 2, 3 and 4 are high-level injuries.
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start10 Sep 2018
- Primary completion10 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guohua Zeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Guohua Zeng, Ph.D and M.D, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717285
- Sponsor's protocol ID
- MRER(75)2018
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Under Direct Vision Versus Under Non Direct Vision for The Efficacy and Safety Ureteral Access Sheath in RIRS for the Management of ≤20mm Size Kidney Stones: A Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03717285
- Acronym / sponsor ID
- MRER(75)2018
- Conditions
- Urolithiasis
- Keywords
- RIRS, Renal stones, ureteral access sheath, ureteral injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Guohua ZengUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 10 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 24 Oct 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.
Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious complications. In long-term clinical practice， the investigators has found that many ureteral injuries occur during UAS insertion of the ureter from ureteral orifice. And if we use rigid ureteroscopy to insert the UAS under direct vision, we can provide the placement success rate and reduce the incidence of complications. The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of under direct vision and under non direct vision during the insertion of UAS.
Detailed description
Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious complications. In long-term clinical practice， the investigators has found that many ureteral injuries occur during UAS insertion of the ureter from ureteral orifice. And if we use rigid ureteroscopy to insert the UAS under direct vision, we can provide the UAS insertion success rate and reduce the incidence of complications.
Options for the UAS insertion include inserted under fluoroscopy control or inserted by the experience of the surgeon. The former is more commonly used in the United States, while the latter is more commonly used in China. But neither is perfect. Moreover, Ibrahim Karabulut et al. and Mehmet Giray Sönmez et al. reported a different technique for placement ureteral access sheath called "Endovisional technique" in which the outer sheath of UAS was worn on the semirigid endoscope and placed into the ureter under direct vision. Nevertheless, They found that complication rate was lower in the patients who had the UAS placed under "Endovisional technique" when compared to the classical technique. But the difference was not statistically significant. In addition, the investigators are concerned that failure to use sheath cores may cause new damage to the ureter.
So the investigators find a new way to insert UAS without damaging the ureter. In our new procedure, the patient is placed in the lithotomy position, and a 0.035'' flexible tip guidewire is placed into the renal pelvis using a ureteroscope. Then take out the ureteroscope and insert the ureteroscope into urinary bladder beside the guidewire. A 12 Fr/ 14 Fr ureteral access sheath (UAS) is advanced into the ureteral over the guidewire under direct vision. When the UAS successfully enters the ureteral orifice a few centimeters, the ureteroscope is removed. Continue inserting the UAS into the proximal ureter or UPJ and use the direct urinary system X-graphy (DUSG) to confirm that the UAS is inserted into the correct position. A P5 or P6 Olympus flexible ureteroscope is passed through the UAS to finish lithotripsy.
Until now, routine technique to insert ureteral access sheath during RIRS is still under discussion. The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of under direct vision and under non direct vision during the insertion of UAS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1:Under direct vision | Experimental | Procedure: Insert the UAS under direct visionPatients in Group 1 insert the UAS under direct vision.In this procedure,the investigators will insert the ureteroscope into urinary bladder beside the guidewire to observe the process of uas insertion into the ureter. |
| Group 2:Under non direct vision | Active comparator | Procedure: Insert the UAS under non direct visionPatients in Group 2 insert the UAS under non direct vision.In this procedure,the investigators will insert the UAS under fluoroscopy control. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be a suitable operative candidate for RIRS
- Age 18 to 70 years
- Normal renal function 4 .ASA score Ⅰ and Ⅱ
- 5. Single renal stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm
Key exclusion criteria (5 listed)
- Patients with solitary kidney
- Uncorrected coagulopathy and active urinary tract infection (UTI)
- Prior ipsilateral endourological procedure history, such as RIRS, PCNL, URS and URL
- Patients who underwent transplant or urinary diversion.
- Congenital abnormalities.
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 |
|---|---|---|
| Insert the UAS under direct visionPatients in this group，we use rigid ureteroscopy to insert the UAS under direct vision. | Procedure or surgery | Group 1:Under direct vision |
| Insert the UAS under non direct visionPatients in this group，we insert the UAS by the experience of the surgeon and under non direct vision . | Procedure or surgery | Group 2:Under non direct vision |
Primary outcome
UAS insertion success rate
Time frame: intraoperatively
Primary insertion of a UAS is not always possible. The ideal position of the UAS is with its distal extremity just below the ureteric-pelvic junction (UPJ). Insertion failure is defined as UAS cross the upj or do not reach the proximal ureter or the surgeon's decision to resign UAS insertion due to high resistance to the retrograde progression of the UAS along the urinary tract.
2 secondary outcomes
Complication rate
Time frame: 1 month after removing the pigtail stent
Ureteral lesion grade
Time frame: intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 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.
Guohua Zeng, Ph.D and M.D study chair
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insert the UAS under direct vision and Insert the UAS under non direct vision in people with Urolithiasis, run by Guohua Zeng at 1 site in China.
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 4 inclusion and 5 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 24 Oct 2018. 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 China. 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?
Contact Guohua Zeng, Ph.D and M.D (+86 13802916676, gzgyzgh@vip.tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UAS insertion success rate (time frame: intraoperatively). 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 24 Oct 2018; AzTrials last refreshed its copy on 4 Nov 2026.