An interventional study of Thulium Fiber laser (TFL) lithotripsy and Ho: YAG lithotripsy in Urolithiasis and Proximal Ureteral Stone, sponsored by Zhongnan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Zhongnan Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
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.
Ho:YAG laser lithotripsy was used in patients with proximal ureteral stones undergoing ureteroscopic lithotripsy.
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
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
Plan to share: No
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This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Zhongnan Hospital