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Efficacy of Semi-rigid Ureteroscopic Laser Lithotripsy in the Treatment of Proximal Ureteral Stones: a Randomized Controlled Trial

Efficacy of Semi-rigid Ureteroscopic Laser Lithotripsy in the Treatment of Proximal Ureteral Stones: a Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06489366
Enrollment
138
Registered
2024-07-05
Start date
2024-06-26
Completion date
2025-02-26
Last updated
2024-07-05

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

Conditions

Proximal Ureteral Stone, Urolithiasis

Keywords

Proximal ureteral stones, Ho: YAG lithotripsy, Thulium Fiber laser (TFL) lithotripsy, Semirigid ureteroscopic lithotripsy

Brief summary

The efficacy of Ho: YAG and TFL combined with semirigid ureteroscopic treatment of proximal ureteral stones will be compared.

Detailed description

The target population of this study is patients with proximal ureteral stones who are scheduled to undergo semirigid ureteroscopic laser lithotripsy. After enrollment, the subjects will be randomly assigned to the semirigid ureteroscopic holmium laser (Ho: YAG) lithotripsy group and the semirigid ureteroscopic thulium fiber laser (TFL) lithotripsy group for surgical treatment. The subjects will be followed up after surgery, and the collected data will be summarized and analyzed after the study.

Interventions

DEVICEThulium Fiber laser (TFL) lithotripsy

Patients with proximal ureteral stones undergoing ureteroscopic lithotripsy using thulium laser lithotripsy.

DEVICEHo: YAG lithotripsy

Ho:YAG laser lithotripsy was used in patients with proximal ureteral stones undergoing ureteroscopic lithotripsy.

Sponsors

Zhongnan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Patients and data analysts were blinded to the allocation measures.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. ≥18 years old; 2. patients diagnosed with unilateral proximal ureteral stones ≤2cm by computed tomography (CT)/Kidney and upper bladder (KUB) radiography who required surgery; 3. patients who volunteered to participate in this study.

Exclusion criteria

1. Unable to give informed consent; 2. Untreated urinary tract infection; 3. Pregnant women; 4. Known anatomical abnormalities (such as urinary diversion or ureteral stenosis); 5. Urothelial tumors, transplanted kidney stones, irreversible coagulopathy; 6. The semi-rigid ureteroscope cannot reach the stone site, ureteroscopy-negative stones, and stones can be removed directly without laser lithotripsy; 7. The researchers believe that they are not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frameDescription
Stone-free rate (SFR)2-4 weeks after surgeryStone-free rate (SFR) after single-session laser lithotripsy using a semirigid ureteroscope without an auxiliary procedure assessed by CT/X-ray at 2-4 weeks follow-up after laser lithotripsy.

Secondary

MeasureTime frameDescription
Operative timeImmediately during surgerythe time of laser lithotripsy
Intraoperative complicationsImmediately during surgerybleeding, ureteral perforation, ureteral wall injury, or intraoperative adverse events leading to termination of surgery
Postoperative complications2-4 weeks after surgeryOccurrence of postoperative complications
Additional proceduresIntraoperatively and before removal of the Ureteral stentsIf semi-rigid ureteroscopy combined with laser lithotripsy fails, it is converted to flexible ureteroscopy, PCNL, laparoscopic lithotomy. In addition, ESWL treatment is performed before the double-J stent is removed after surgery.lithotripsy, and postoperative ESWL treatment before removal of the ureteral stents, among others.

Countries

China

Contacts

Primary ContactXinghuan Wang
wangxinghuan@whu.edu.cn+86 18770426026

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026