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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongnan Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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.

Disqualifiers

Unable to give informed consent;

Untreated urinary tract infection;

Pregnant women;

Known anatomical abnormalities (such as urinary diversion or ureteral stenosis);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thulium Fiber laser (TFL) lithotripsy

    Device

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

  • Ho: YAG lithotripsy

    Device

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

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Ho: YAG lithotripsyActive comparator 1 intervention
Group B: Thulium Fiber laser (TFL) lithotripsyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
2-4 weeks after surgery

Secondary outcomes

1

Operative time

the time of laser lithotripsy

Time frame
Immediately during surgery
2

Intraoperative complications

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

Time frame
Immediately during surgery
3

Postoperative complications

Occurrence of postoperative complications

Time frame
2-4 weeks after surgery
4

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

Other outcomes

Sponsors and contacts

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