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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Urolithiasis; Proximal Ureteral Stone
• Intervention / Treatment: Device: Ho: YAG lithotripsy; Device: Thulium Fiber laser (TFL) lithotripsy

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 Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinghuan Wang; Phone Number: +86 18770426026; Email: wangxinghuan@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital, Wuhan University,
      • Contact: Xinghuan Wang; Phone Number: +86 18770426026; Email: wangxinghuan@whu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Ho: YAG lithotripsy; Ho:YAG laser lithotripsy was used in patients with proximal ureteral stones undergoing ureteroscopic lithotripsy.
Experimental: 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.	Device: Thulium Fiber laser (TFL) lithotripsy; Patients with proximal ureteral stones undergoing ureteroscopic lithotripsy using thulium laser lithotripsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone-free rate (SFR)	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.	2-4 weeks after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 26, 2024
• Primary Completion (Estimated): January 26, 2025
• Study Completion (Estimated): February 26, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Proximal ureteral stones; Ho: YAG lithotripsy; Thulium Fiber laser (TFL) lithotripsy; Semirigid ureteroscopic lithotripsy
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urolithiasis; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: 20240173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No