Evaluating the Efficacy of Litho Vue Elite for ECIRS

Prospective randomized control trial analyzing the efficacy of LithoVue Elite on postoperative infection of endoscopic combined intrarenal surgery (ECIRS) - Elite ECIRS-2023

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042240139

Enrollment

150

Registered

2024-12-09

Start date

2025-02-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

upper tract urinary calculi Kidney calculi

Interventions

This randomised study aimed to evaluate the efficacy of intraoperative IPP monitoring on postoperative infection of ECIRS comparing LithoVue Elite to LithoVue.

D000074642

ECIRS, Intrarenal pressure, Litho Vue Elite

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who will be performed ECIRS for upper tract urinary calculi at the Nagoya City University Hospital or Ngaoya City University East Medical Center 2. Age at the time of informed consent is between 25 and 85 years old 3. Written informed consent from patient to participate in the study, including compliance with study procedures

Exclusion criteria

Exclusion criteria: 1. Patients with coagulation abnormality or unable to discontinue anticoagulants 2. Pregnant or possibly pregnant or breastfeeding women 3. Patients who are not be able to do general anesthesia 4. Patients unable to maintain the surgical position (prone split-leg position) 5. Patients with active febrile urinary tract infection 6. Patients after urinary diversion 7. Patients with preoperative nephrostomy insertion 8. Patients who cannot be inserted ureteroscopy due to severe ureteral stricture 9. Other patients for whom the investigator or sub-investigator judges the subject to be inappropriate

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative fever (a temperature >38.5 for at least 1 day or >38.0 for more than 2 days) during hospitalization	—

Secondary

Measure	Time frame
1. Surgical time 2. Total time with excessive IRP (>30mmHg) 3. Number of SIRS criteria (Body temperature, Herat rate, Respiratory rate, WBC) 4. quick SOFA (qSOFA:Respiratory rate, Altered mental status, Systolic BP) 5. Intraoperative inflammatory markers (WBC, CRP) 6. Number of times postoperative analgesics used 7. Postoperative Inflammatory marker (WBC, CRP) 8. Stone free rate 9. Postoperative complications (Clavien Dindo Classification) 10. Wisconsin QOL score	—

Measure

Time frame

1. Surgical time 2. Total time with excessive IRP (>30mmHg) 3. Number of SIRS criteria (Body temperature, Herat rate, Respiratory rate, WBC) 4. quick SOFA (qSOFA:Respiratory rate, Altered mental status, Systolic BP) 5. Intraoperative inflammatory markers (WBC, CRP) 6. Number of times postoperative analgesics used 7. Postoperative Inflammatory marker (WBC, CRP) 8. Stone free rate 9. Postoperative complications (Clavien Dindo Classification) 10. Wisconsin QOL score

—

Contacts

Public ContactShuzo Hamamoto

Nagoya City University Hospital

hamamo10@med.nagoya-cu.ac.jp+81-52-853-8266

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026