Stone, KidneyNCT05340088
Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
An observational study of Stone, Kidney and Urolithiasis, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Retrograde intrarenal surgery (RIRC) is used as standard treatment for stones less than 2 cm. In some cases, the ureteral access sheath cannot be placed due to ureteral stricture. In this case, a double j stent (DJ) is placed to passively dilate the ureter, and the RIRC is postponed for post-dilatation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stone, Kidney, Urolithiasis
- What is being tested?
- Retrograde intrarenal surgery after DJ stent placement
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Feb 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a DJ stent for passive dilatation and subsequent RIRC
Who may be able to join
- Patients with a DJ stent for passive dilatation and subsequent RIRC
Who cannot join
- Urinary tract infection, patients with ureteral compression and a history of pelvic radiotherapy, urinary system tumor
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Altindag, 06230
About this study
Retrograde intrarenal surgery (RIRC) is used as standard treatment for stones less than 2 cm. In some cases, the ureteral access sheath cannot be placed due to ureteral stricture. In this case, a double j stent (DJ) is placed to passively dilate the ureter, and the RIRC is postponed for post-dilatation. The aim of the study is to determine the optimal time for RIRC operation in cases where a double j stent was placed for passive dilatation.
- Conditions
- Stone, Kidney, Urolithiasis
- Being tested
- Retrograde intrarenal surgery after DJ stent placement
- Medical subject headings
- Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde intrarenal surgery after DJ stent placementProcedure or surgery
Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation | Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation Receives: Procedure: Retrograde intrarenal surgery after DJ stent placement | |
| Patients who underwent RIRC for 4-6 weeks after DJ stent placement for passive dilatation | Patients who underwent RIRC for 4-6 weeks after DJ stent placement for passive dilatation Receives: Procedure: Retrograde intrarenal surgery after DJ stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI in kg/m^2
BMI in kg/m^2the kidney, operation time(minute)
Measured: 3 Months
serum creatinine mg/dl
serum creatinine mg/dl
Measured: 3 Months
Secondary outcomes (2)
mm size of the stone
mm size of the stone
Measured: 3 Months
localization of the stone in the kidney,
localization of the stone in the kidney,
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Sep 2021
- Primary completion1 Jan 2022
- Study completion1 Feb 2022
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 Stone, KidneyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340088
- Sponsor's protocol ID
- DJRIRS2022
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bai PD, Wang T, Huang HC, Wu Z, Wang XG, Qin JX, Wang HQ, Chen B, Hu MB, Xing JC. Effect of Preoperative Double-J Ureteral Stenting before Flexible Ureterorenoscopy on Stone-free Rates and Complications. Curr Med Sci. 2021 Feb;41(1):140-144. doi: 10.1007/s11596-021-2328-z. Epub 2021 Feb 13.
PubMed 33582918Yuk HD, Park J, Cho SY, Sung LH, Jeong CW. The effect of preoperative ureteral stenting in retrograde Intrarenal surgery: a multicenter, propensity score-matched study. BMC Urol. 2020 Sep 14;20(1):147. doi: 10.1186/s12894-020-00715-1.
PubMed 32928162
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
- ClinicalTrials.gov ID
- NCT05340088
- Acronym / sponsor ID
- DJRIRS2022
- Conditions
- Stone, Kidney, Urolithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 21 Apr 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.
Retrograde intrarenal surgery (RIRC) is used as standard treatment for stones less than 2 cm. In some cases, the ureteral access sheath cannot be placed due to ureteral stricture. In this case, a double j stent (DJ) is placed to passively dilate the ureter, and the RIRC is postponed for post-dilatation. The aim of the study is to determine the optimal time for RIRC operation in cases where a double j stent was placed for passive dilatation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation | – | Procedure: Retrograde intrarenal surgery after DJ stent placementPatients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation |
| Patients who underwent RIRC for 4-6 weeks after DJ stent placement for passive dilatation | – | Procedure: Retrograde intrarenal surgery after DJ stent placementPatients who underwent RIRC for 4-6 weeks after DJ stent placement for passive dilatation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a DJ stent for passive dilatation and subsequent RIRC
Key inclusion criteria (1 listed)
- Patients with a DJ stent for passive dilatation and subsequent RIRC
Key exclusion criteria (1 listed)
- Urinary tract infection, patients with ureteral compression and a history of pelvic radiotherapy, urinary system tumor
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 |
|---|---|---|
| Retrograde intrarenal surgery after DJ stent placementPatients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation | Procedure or surgery | Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation, Patients who underwent RIRC for 4-6 weeks after DJ stent placement for passive dilatation |
Primary outcome
BMI in kg/m^2
Time frame: 3 Months
BMI in kg/m^2the kidney, operation time(minute)
serum creatinine mg/dl
Time frame: 3 Months
serum creatinine mg/dl
2 secondary outcomes
mm size of the stone
Time frame: 3 Months
localization of the stone in the kidney,
Time frame: 3 Months
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 21 Apr 2022.
- Background: PubMed 33582918Bai PD, Wang T, Huang HC, Wu Z, Wang XG, Qin JX, Wang HQ, Chen B, Hu MB, Xing JC. Effect of Preoperative Double-J Ureteral Stenting before Flexible Ureterorenoscopy on Stone-free Rates and Complications. Curr Med Sci. 2021 Feb;41(1):140-144. doi: 10.1007/s11596-021-2328-z. Epub 2021 Feb 13.
- Background: PubMed 32928162Yuk HD, Park J, Cho SY, Sung LH, Jeong CW. The effect of preoperative ureteral stenting in retrograde Intrarenal surgery: a multicenter, propensity score-matched study. BMC Urol. 2020 Sep 14;20(1):147. doi: 10.1186/s12894-020-00715-1.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stone, Kidney and Urolithiasis, 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 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 21 Apr 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 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. 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?
BMI in kg/m^2 (time frame: 3 Months). The study lists 2 primary outcomes in all. 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 NCT05340088, 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 21 Apr 2022; AzTrials last refreshed its copy on 2 Nov 2026.