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

N/ANot Yet RecruitingNCT06489366

Zhongnan Hospital138 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

138

Conditions

Urolithiasis Proximal Ureteral Stone

Interventions

Thulium Fiber laser (TFL) lithotripsyDEVICE

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

Ho: YAG lithotripsyDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhongnan Hospital, Wuhan University,

Wuhan, Hubei, China

Outcomes

Primary Outcomes

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.

Time frame: 2-4 weeks after surgery

Secondary Outcomes

Operative time

the time of laser lithotripsy

Time frame: Immediately during surgery

Intraoperative complications

bleeding, ureteral perforation, ureteral wall injury, or intraoperative adverse events leading to termination of surgery

Time frame: Immediately during surgery

Postoperative complications

Occurrence of postoperative complications

Time frame: 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.

Time frame: Intraoperatively and before removal of the Ureteral stents

Central Contacts

Xinghuan Wang

CONTACT

+86 18770426026 wangxinghuan@whu.edu.cn

Data from ClinicalTrials.gov

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