Kidney StonesNCT05231577
7.5F Versus 9.2F Flexible Ureteroscopy for the Treatment of 1-2cm Renal Calculi on Postoperative Infection
A study testing 7.5fr ultra-fine ureteroscopy and 9.2fr Ureteroscopy in people with Kidney Stones, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Ureteroscopic lithotripsy (RIRS) is the first-line treatment for 1-2 cm upper urinary tract stones, and the stone clearance rate can reach 81.4% - 92.5%. Fever after RIRS is the most common infection after RIRS, and its incidence is up to 20%. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Stones
- What is being tested?
- 7.5fr ultra-fine ureteroscopy and 9.2fr Ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 31 Aug 2022
- 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
- Agree to receive ureteroscopy
- Aged 18-70 years. 3.1-2cm kidney stones
Who cannot join
- Combined with middle and lower ureteral calculi, surgical operation other than RIRS is required;
- Patients with abnormal anatomical structure, ureteral stenosis and urinary diversion, such as ectopic kidney, horseshoe kidney and duplicate kidney;
- Patients who have undergone nephrostomy;
- Severe cardiopulmonary insufficiency;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Urology, Minimally invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong,China, 510230
Guohua Zeng, Ph.D & MD, +8613802916676, gzgyzgh@vip.sina.com
Wen Zhong, Ph.D & MD, +8613631320020, gzgyzhongwen@163.com
About this study
Official title: 7.5F Versus 9.2F Flexible Ureteroscopy for the Treatment of 1-2cm Renal Calculi on Postoperative Infection:An International Multicenter Randomized Controlled Trial
Ureteroscopic lithotripsy (RIRS) is the first-line treatment for 1-2 cm upper urinary tract stones, and the stone clearance rate can reach 81.4% - 92.5%. Fever after RIRS is the most common infection after RIRS, and its incidence is up to 20%. The incidence rate of systemic inflammatory response syndrome is 6.5% - 10.3%, sepsis 0.1% - 4.3%, with the infection progressed. If there is no timely and effective intervention in the early stage of urogenic sepsis, it can progress to septic shock, and the mortality can be as high as 30% - 40%. High intrarenal pressure is an important risk factor for postoperative infection. American Urological Association (AUA) guidelines point out that controlling intrarenal pressure at an appropriate level is particularly important to prevent postoperative infection.
The use of ureteroscopic sheath in ureteroscopic surgery can effectively reduce the intrarenal pressure, which is an important measure to reduce the incidence of postoperative infection. Theoretically, the larger the space, the better the reflux effect and the lower the incidence of postoperative infection. The study showed that the incidence of ureteral sheath infection was significantly lower than that of ureteral sheath infection after operation. When using the same caliber ureteroscopic sheath, use a smaller caliber ureteroscopy to increase the space between the ureteroscopy and the ureteral sheath, promote reflux, reduce intrarenal pressure and reduce the incidence of postoperative infection. However, there is still a lack of relevant research on the effect of different caliber ureteroscopy in the treatment of renal calculi on postoperative infection.
- Conditions
- Kidney Stones
- Being tested
- 7.5fr ultra-fine ureteroscopy, 9.2fr Ureteroscopy
- Keywords
- ureteroscopy, postoperative fever, renal calculi
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.5fr ultra-fine ureteroscopyProcedure or surgery
The patient placed the lithotomy position, placed the ureteroscope to explore the affected ureter, retrogradely placed the guide wire, and placed the 12 / 14fr ureteral sheath under X-ray monitoring until the affected ureter was close to the outlet of the renal pelvis. Group 1 patients used 7.5fr ultra-fine ureteroscopy
9.2fr UreteroscopyProcedure or surgery
The patient placed the lithotomy position, placed the ureteroscope to explore the affected ureter, retrogradely placed the guide wire, and placed the 12 / 14fr ureteral sheath under X-ray monitoring until the affected ureter was close to the outlet of the renal pelvis. Group 2 patients used 9.2fr Ureteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Patients in Group 0 undergo 7.5fr ultra-fine ureteroscopy | Experimental | Not described Receives: Procedure: 7.5fr ultra-fine ureteroscopy |
| Experimental: Patients in Group 2 undergo 9.2fr ureteroscopy | Experimental | Not described Receives: Procedure: 9.2fr Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative fever
Postoperative fever was defined as armpit temperature ≥38C
Measured: ≤ 1month postoperatively
Secondary outcomes (1)
Stone free rate (SFR)
2mm Non-contrast CT is obtained for all patients at one month after removing the pigtail stent to evaluate the final SFR. Stone-free status are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were definded as ≤ 4mm, asymptomatic, non-obstructive and non-infectious stone particles
Measured: 1 month after removing the pigtail stent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Feb 2022 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Guohua Zeng, Ph.D & MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231577
- Sponsor's protocol ID
- RCT(2022)
- Status last verified
- Jan 2022
- First submitted
- 31 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elashry OM, Elbahnasy AM, Rao GS, Nakada SY, Clayman RV. Flexible ureteroscopy: Washington University experience with the 9.3F and 7.5F flexible ureteroscopes. J Urol. 1997 Jun;157(6):2074-80. doi: 10.1016/s0022-5347(01)64677-9.
PubMed 9146583Zhong W, Zhu W, Zhao Z, Liao B, Mai H, Liu C, Wang K, Zhang X, Xu C, Zeng G. 7.5F Mini Flexible Ureteroscope in Retrograde Intrarenal Surgery: Initial Results from a Multicenter Randomized Clinical Trial. J Endourol. 2024 May;38(5):421-425. doi: 10.1089/end.2023.0540. Epub 2024 Apr 4.
PubMed 38299514
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7.5F Versus 9.2F Flexible Ureteroscopy for the Treatment of 1-2cm Renal Calculi on Postoperative Infection:An International Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05231577
- Acronym / sponsor ID
- RCT(2022)
- Conditions
- Kidney Stones
- Keywords
- ureteroscopy, postoperative fever, renal calculi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 9 Feb 2022 (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.
Ureteroscopic lithotripsy (RIRS) is the first-line treatment for 1-2 cm upper urinary tract stones, and the stone clearance rate can reach 81.4% - 92.5%. Fever after RIRS is the most common infection after RIRS, and its incidence is up to 20%. The incidence rate of systemic inflammatory response syndrome is 6.5% - 10.3%, sepsis 0.1% - 4.3%, with the infection progressed. If there is no timely and effective intervention in the early stage of urogenic sepsis, it can progress to septic shock, and the mortality can be as high as 30% - 40%. High intrarenal pressure is an important risk factor for postoperative infection. American Urological Association (AUA) guidelines point out that controlling intrarenal pressure at an appropriate level is particularly important to prevent postoperative infection.
The use of ureteroscopic sheath in ureteroscopic surgery can effectively reduce the intrarenal pressure, which is an important measure to reduce the incidence of postoperative infection. Theoretically, the larger the space, the better the reflux effect and the lower the incidence of postoperative infection. The study showed that the incidence of ureteral sheath infection was significantly lower than that of ureteral sheath infection after operation. When using the same caliber ureteroscopic sheath, use a smaller caliber ureteroscopy to increase the space between the ureteroscopy and the ureteral sheath, promote reflux, reduce intrarenal pressure and reduce the incidence of postoperative infection. However, there is still a lack of relevant research on the effect of different caliber ureteroscopy in the treatment of renal calculi on postoperative infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Patients in Group 0 undergo 7.5fr ultra-fine ureteroscopy | Experimental | Procedure: 7.5fr ultra-fine ureteroscopy |
| Experimental: Patients in Group 2 undergo 9.2fr ureteroscopy | Experimental | Procedure: 9.2fr Ureteroscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Agree to receive ureteroscopy
- Aged 18-70 years. 3.1-2cm kidney stones
Key exclusion criteria (5 listed)
- Combined with middle and lower ureteral calculi, surgical operation other than RIRS is required;
- Patients with abnormal anatomical structure, ureteral stenosis and urinary diversion, such as ectopic kidney, horseshoe kidney and duplicate kidney;
- Patients who have undergone nephrostomy;
- Severe cardiopulmonary insufficiency;
- Pregnant women.
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 |
|---|---|---|
| 7.5fr ultra-fine ureteroscopyThe patient placed the lithotomy position, placed the ureteroscope to explore the affected ureter, retrogradely placed the guide wire, and placed the 12 / 14fr ureteral sheath under X-ray monitoring until the affected ureter was close to the outlet of the renal pelvis. Group 1 patients used 7.5fr ultra-fine ureteroscopy | Procedure or surgery | Experimental: Patients in Group 0 undergo 7.5fr ultra-fine ureteroscopy |
| 9.2fr UreteroscopyThe patient placed the lithotomy position, placed the ureteroscope to explore the affected ureter, retrogradely placed the guide wire, and placed the 12 / 14fr ureteral sheath under X-ray monitoring until the affected ureter was close to the outlet of the renal pelvis. Group 2 patients used 9.2fr Ureteroscopy | Procedure or surgery | Experimental: Patients in Group 2 undergo 9.2fr ureteroscopy |
Primary outcome
postoperative fever
Time frame: ≤ 1month postoperatively
Postoperative fever was defined as armpit temperature ≥38C
1 secondary outcome
Stone free rate (SFR)
Time frame: 1 month after removing the pigtail stent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Background: PubMed 9146583Elashry OM, Elbahnasy AM, Rao GS, Nakada SY, Clayman RV. Flexible ureteroscopy: Washington University experience with the 9.3F and 7.5F flexible ureteroscopes. J Urol. 1997 Jun;157(6):2074-80. doi: 10.1016/s0022-5347(01)64677-9.
- Derived from this study: PubMed 38299514Zhong W, Zhu W, Zhao Z, Liao B, Mai H, Liu C, Wang K, Zhang X, Xu C, Zeng G. 7.5F Mini Flexible Ureteroscope in Retrograde Intrarenal Surgery: Initial Results from a Multicenter Randomized Clinical Trial. J Endourol. 2024 May;38(5):421-425. doi: 10.1089/end.2023.0540. Epub 2024 Apr 4.
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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 & MD principal investigator
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 7.5fr ultra-fine ureteroscopy and 9.2fr Ureteroscopy in people with Kidney Stones, run by The First Affiliated Hospital of Guangzhou Medical University 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 2 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 9 Feb 2022. 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 & MD (+86 13802916676, gzgyzgh@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative fever (time frame: ≤ 1month postoperatively). 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 NCT05231577, which also lists 2 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 9 Feb 2022.