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

NCT06489366 | Not Yet Recruiting

• 1 other identifier: 20240173
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urolithiasis; Proximal Ureteral Stone

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Operative time

  Immediately during surgery

• Intraoperative complications

  Immediately during surgery

• Postoperative complications

  2-4 weeks after surgery

• Additional procedures

  Intraoperatively and before removal of the Ureteral stents

Study Arms (2)

Ho: YAG lithotripsy

ACTIVE COMPARATOR

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

Thulium Fiber laser (TFL) lithotripsy

EXPERIMENTAL

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

Interventions

Thulium Fiber laser (TFL) lithotripsy DEVICE

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

Thulium Fiber laser (TFL) lithotripsy

Ho: YAG lithotripsy DEVICE

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

Ho: YAG lithotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital, Wuhan University,

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Urolithiasis

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Xinghuan Wang

CONTACT

+86 18770426026; wangxinghuan@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients and data analysts were blinded to the allocation measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: June 26, 2024
• Primary Completion: January 26, 2025
• Study Completion: February 26, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)