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

Not Applicable

Not yet recruiting

• Conditions: Proximal Ureteral Stone; Urolithiasis
• Interventions: Device: Thulium Fiber laser (TFL) lithotripsy

• Registration Number: NCT06489366
• Lead Sponsor: Zhongnan Hospital

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.

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-26
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-01-26
• Study Completion: 2025-02-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thulium Fiber laser (TFL) lithotripsy	Thulium Fiber laser (TFL) lithotripsy	The patient adopts lithotomy position. After general anesthesia, a semi-rigid ureteroscope is used to enter the bladder through the urethra to observe the ureteral opening, and then a hydrophilic guide wire is inserted into the ureter on the affected side. After the semi-rigid ureteroscope slowly enters along the hydrophilic guide wire and reaches the bottom of the stone, the laser fiber of the laser therapy machine is inserted into the working channel of the ureteroscope so that the end of the fiber is exposed to the field of view of the ureteroscope. Using the TFL laser therapy device, after setting the lithotripsy parameters, the fiber is aimed at the stone for laser lithotripsy.

Primary Outcome Measures

Name	Time	Method
Stone-free rate (SFR)	2-4 weeks after surgery	Stone-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 Outcome Measures

Name	Time	Method
Intraoperative complications	Immediately during surgery	bleeding, ureteral perforation, ureteral wall injury, or intraoperative adverse events leading to termination of surgery
Operative time	Immediately during surgery	the time of laser lithotripsy
Postoperative complications	2-4 weeks after surgery	Occurrence of postoperative complications
Additional procedures	Intraoperatively and before removal of the Ureteral stents	If 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.

Trial Locations

Locations (1)

Zhongnan Hospital, Wuhan University,; 🇨🇳 Wuhan, Hubei, China