Upper Urinary Tract CalculiNCT07616505
A Comparative Study of Three Ureteral Stenting Strategies After Ureteroscopic Lithotripsy for Upper Urinary Tract Calculi
A study testing Upper urinary tract calculi in people with Upper Urinary Tract Calculi, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
In recent years, with the widespread popularization of the enhanced recovery after surgery (ERAS) concept, tubeless ureteroscopic lithotripsy (URL) has gradually become a research hotspot. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Upper Urinary Tract Calculi
- What is being tested?
- Upper urinary tract calculi
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years; diagnosed with unilateral upper urinary tract calculi (ureteral calculi or renal pelvic/calyceal calculi, diameter ≤2 cm) by computed tomography (CT) or ultrasonography.
- Scheduled for ureteroscopic lithotripsy (URL), including rigid or flexible ureteroscopy.
Who cannot join
- Patients undergoing bilateral surgery. Pregnant or lactating women. Patients with pre-existing ureteral stents at the time of ureteroscopy. Patients with anatomical abnormalities (e.g., horseshoe kidney, pelvic kidney, solitary kidney) or renal transplant recipients.
- Patients with systemic infectious manifestations. Patients unable to provide informed consent. Patients with uncontrolled coagulopathy, severe preoperative hydronephrosis or pyonephrosis.
- Patients with incomplete clearance of stone fragments during primary ureteroscopic lithotripsy (URSL).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
In recent years, with the widespread popularization of the enhanced recovery after surgery (ERAS) concept, tubeless ureteroscopic lithotripsy (URL) has gradually become a research hotspot. Multiple studies have indicated that tubeless management may be safe and feasible for strictly selected low-risk patients, and can prevent stent-related complications. Nevertheless, high-quality three-arm controlled trial evidence is still lacking regarding whether complete tubeless management is applicable to all patients with conventional urolithiasis, and whether an optimal time window exists to balance safety and comfort when ureteral stenting is mandatory. Most existing studies only compare stenting versus non-stenting, or long-term versus short-term stenting, without systematic comparison of tubeless management, short-term stenting (1-week indwelling) and conventional stenting (2-week indwelling) within a unified framework.
In summary, although URL techniques have matured, numerous uncertainties remain in postoperative ureteral stent management strategies. Rigorously designed prospective studies are urgently needed in clinical practice to comprehensively evaluate differences in complication control, patient quality of life (assessed by the Ureteral Stent Symptom Questionnaire [USSQ]), unplanned readmission rates and health-economic costs among three management modalities: tubeless approach, stent removal at postoperative 1 week and stent removal at postoperative 2 weeks. This study aims to fill this evidence gap, provide high-level evidence-based medical references for urologists to develop individualized and precise postoperative ureteral stent management protocols, and ultimately achieve dual optimization of patients' recovery speed and quality of life.
- Conditions
- Upper Urinary Tract Calculi
- Being tested
- Upper urinary tract calculi
- Keywords
- tubeless, ureteroscopic lithotripsy, Upper urinary tract calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper urinary tract calculiProcedure or surgery
Also called Double-J stent indwelling for 1 week postoperatively, Double-J stent indwelling for 2 weeks postoperatively
Group A (Tubeless Group): No Double-J stent is placed after confirming no severe injury or significant residual calculi upon surgery completion. Postoperative routine anti-inflammatory treatment and fluid infusion are administered.
Group B (1-Week Stent Group): A 4.7Fr or 6Fr Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 7 (±1 day).
Group C (2-Week Stent Group): The same type of Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 14 (±2 days).
Standardization: All operations are performed by the same team of senior attending physicians with identical brand laser devices and stents. Perioperative medication regimens are consistent across all groups.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group1 | Experimental | Double-J stent indwelling for 1 week postoperatively Receives: Procedure: Upper urinary tract calculi |
| Intervention group2 | Experimental | no Double-J stent insertion Receives: Procedure: Upper urinary tract calculi |
| Control group | Other | Double-J stent indwelling for 2 weeks postoperatively Receives: Procedure: Upper urinary tract calculi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative complications
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start12 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Urinary Tract CalculiStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616505
- Sponsor's protocol ID
- 2026-0280
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Three Ureteral Stenting Strategies After Ureteroscopic Lithotripsy for Upper Urinary Tract Calculi
- ClinicalTrials.gov ID
- NCT07616505
- Acronym / sponsor ID
- 2026-0280
- Conditions
- Upper Urinary Tract Calculi
- Keywords
- tubeless, ureteroscopic lithotripsy, Upper urinary tract calculi
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 12 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jun 2026 (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.
In recent years, with the widespread popularization of the enhanced recovery after surgery (ERAS) concept, tubeless ureteroscopic lithotripsy (URL) has gradually become a research hotspot. Multiple studies have indicated that tubeless management may be safe and feasible for strictly selected low-risk patients, and can prevent stent-related complications. Nevertheless, high-quality three-arm controlled trial evidence is still lacking regarding whether complete tubeless management is applicable to all patients with conventional urolithiasis, and whether an optimal time window exists to balance safety and comfort when ureteral stenting is mandatory. Most existing studies only compare stenting versus non-stenting, or long-term versus short-term stenting, without systematic comparison of tubeless management, short-term stenting (1-week indwelling) and conventional stenting (2-week indwelling) within a unified framework.
In summary, although URL techniques have matured, numerous uncertainties remain in postoperative ureteral stent management strategies. Rigorously designed prospective studies are urgently needed in clinical practice to comprehensively evaluate differences in complication control, patient quality of life (assessed by the Ureteral Stent Symptom Questionnaire [USSQ]), unplanned readmission rates and health-economic costs among three management modalities: tubeless approach, stent removal at postoperative 1 week and stent removal at postoperative 2 weeks. This study aims to fill this evidence gap, provide high-level evidence-based medical references for urologists to develop individualized and precise postoperative ureteral stent management protocols, and ultimately achieve dual optimization of patients' recovery speed and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group1 | Experimental | Procedure: Upper urinary tract calculiDouble-J stent indwelling for 1 week postoperatively |
| Intervention group2 | Experimental | Procedure: Upper urinary tract calculino Double-J stent insertion |
| Control group | Other | Procedure: Upper urinary tract calculiDouble-J stent indwelling for 2 weeks postoperatively |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥18 years; diagnosed with unilateral upper urinary tract calculi (ureteral calculi or renal pelvic/calyceal calculi, diameter ≤2 cm) by computed tomography (CT) or ultrasonography.
- Scheduled for ureteroscopic lithotripsy (URL), including rigid or flexible ureteroscopy.
Key exclusion criteria (3 listed)
- Patients undergoing bilateral surgery. Pregnant or lactating women. Patients with pre-existing ureteral stents at the time of ureteroscopy. Patients with anatomical abnormalities (e.g., horseshoe kidney, pelvic kidney, solitary kidney) or renal transplant recipients.
- Patients with systemic infectious manifestations. Patients unable to provide informed consent. Patients with uncontrolled coagulopathy, severe preoperative hydronephrosis or pyonephrosis.
- Patients with incomplete clearance of stone fragments during primary ureteroscopic lithotripsy (URSL).
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 |
|---|---|---|
| Upper urinary tract calculiAlso: Double-J stent indwelling for 1 week postoperatively, Double-J stent indwelling for 2 weeks postoperativelyGroup A (Tubeless Group): No Double-J stent is placed after confirming no severe injury or significant residual calculi upon surgery completion. Postoperative routine anti-inflammatory treatment and fluid infusion are administered. Group B (1-Week Stent Group): A 4.7Fr or 6Fr Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 7 (±1 day). Group C (2-Week Stent Group): The same type of Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 14 (±2 days). Standardization: All operations are performed by the same team of senior attending physicians with identical brand laser devices and stents. Perioperative medication regimens are consistent across all groups. | Procedure or surgery | Control group, Intervention group1, Intervention group2 |
Primary outcome
Incidence of postoperative complications
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Upper urinary tract calculi in people with Upper Urinary Tract Calculi, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 3 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: opening soon, as of the sponsor's last update on 1 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong He (+8613757118231, zrhh@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative complications (time frame: 1 month). 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 1 Jun 2026.