Vsuatlization modality (US vs X-ray) for the outcome of ESWL

JRCT ID: jRCT1042200031

Registered date:10/07/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: urolithiasis
• Date of first enrollment: 27/07/2020
• Target sample size: 160
• Study type: Interventional

Intervention(s)

US group: Stoens will be targeted by ultrasonogralhy and fluoroscopy during SWL
X-ray group: Stones will be targete by fluoroscopy only during SWL

Outcome(s)

• Primary Outcome: Stone free rate at one month after SWL by KUB and ultrasonography

Secondary Outcome

1, Stone free rate at three months after SWL by CT
2, Surgical time
3, Fluoroscopic time
4, Surgical complications
5, Total numuber of shocks during ESWL
6, Total energy during ESWL

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Patients whose age are between 16 and 80 years old, diagnosed with renal and/or upper ureteral stone at Nagoya City University Hospital, and planned for shock wave lithotripsy (SWL)
2) Patients whose stone was detected by ultrasonography
3) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 or 1
4) stone size: 5-15mm
5) Hydonephrosis: less than Grade 3 (Ellenbogen classification)
6) No previous treatments for the targeted stone
7) Duration between diagnosis date and ESWL
8) Patients who were obtained written informed consent
- obtained written informed consent from themselves if they are 20 years old and older
- obtained written informed consent from themselves and representatives are between 16 and 19 years old

Exclude criteria

A) women with pregnant or its possibility
B) patients with coagulation abnormalities
C) difficult status for keeping the stable position
D) DJ stent placement before SWL
E) nephrostomy placement before SWL
F) patients with urinary diversion

Related Information

• Primary Sponsor: Hamamoto Shuzo