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Application of direct-view balloon dilatation in one-stage flexible ureteroscopy: a multicenter, randomized, control trial

Application of direct-view balloon dilatation in one-stage flexible ureteroscopy: a multicenter, randomized, control trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039250
Enrollment
Unknown
Registered
2020-10-22
Start date
2020-11-15
Completion date
Unknown
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper urinary tract calculi

Interventions

Balloon dilatation group:Balloon dilatation of ureter under direct vision
Traditional treatment group:Ureteroscopic dilatation to attempt into the sheath

Sponsors

Shanghai Pudong New Area Gongli Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. In patients with renal pelvis, calyces and upper ureteral calculi, the length and diameter are less than 2.0 cm, and ESWL is difficult to handle, fail or remain (difficult to locate, hard calculi or incarcerated calculi with long residence time, etc.). 2. The patients with extreme obesity and severe spinal deformity are not suitable for percutaneous nephrolithotomy. 3. Patients with symptomatic calyceal diverticulum stones with calyceal neck stenosis.

Exclusion criteria

Exclusion criteria: 1. Special population (patients beyond 18-70 years old and pregnant women); 2. Patients with renal calculi larger than 2cm in diameter, patients with renal infection and infectious calculi; 3. One stage contralateral patients (percutaneous nephrolithotomy, ureteroscopic lithotripsy, RIRS); 4. Patients with ureteral stricture above 3cm and ureteral atresia confirmed by preoperative imaging; 5. Patients with malignant ureteral stricture caused by tumor compression and invasion; 6. Renal transplant patients; 7. Patients who cannot stop the use of anticoagulants; 8. Patients with bleeding tendency; 9. Patients with severe cardiopulmonary insufficiency; 10. Patients with severe hip deformity.

Design outcomes

Primary

MeasureTime frame
Success rate of one-stage sheath insertion;

Secondary

MeasureTime frame
Success rate of one-stage operation;Operation time;Stone Free Rate;Ureteral injury rate;bleeding rate;infection rate;pain score;hospitalization days;the cost of treatment;patient satisfaction score;incidence of long-term ureteral stricture;

Countries

China

Contacts

Public ContactCui Xingang

Shanghai Pudong new area Gongli Hospital

cuixingang@163.com+86 13764346288

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026