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

NCT ID: NCT06489366

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-26
• Study Completion Date: 2025-02-26

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.

Conditions

Urolithiasis; Proximal Ureteral Stone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ho: YAG lithotripsy

Ho; YAG laser therapy device is used. 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 optical fiber of the laser therapy device is inserted into the working channel of the ureteroscope so that the end of the optical fiber is exposed in the field of view of the ureteroscope. After the laser therapy device sets the lithotripsy parameters, the optical fiber is aimed at the stone for laser lithotripsy.

Group Type: ACTIVE_COMPARATOR

Ho: YAG lithotripsy

Intervention Type: DEVICE

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

Group Type: EXPERIMENTAL

Thulium Fiber laser (TFL) lithotripsy

Intervention Type: DEVICE

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

Interventions

Thulium Fiber laser (TFL) lithotripsy

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

Intervention Type: DEVICE

Ho: YAG lithotripsy

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongnan Hospital, Wuhan University,

Wuhan, Hubei, China

Countries

China

Central Contacts

Xinghuan Wang

Role: CONTACT

wangxinghuan@whu.edu.cn

+86 18770426026

Facility Contacts

Xinghuan Wang

Role: primary

wangxinghuan@whu.edu.cn

+86 18770426026

Other Identifiers

20240173

Identifier Type: -

Identifier Source: org_study_id