Fluoroscopy Activation Interval in SWL

Lütfi Kırdar City Hospital

Status: Completed

Conditions: Kidney Calculi

Treatments: Device: Shock wave lithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06689683

Canakci0001

Details and patient eligibility

About

Shock wave lithotripsy (SWL) is a noninvasive method widely used as the first step in treating stone disease. This study aimed to reduce radiation exposure to patients and practitioners during SWL sessions by extending the intervals of fluoroscopy controls. The main questions it aims to answer are:

• Will radiation exposure be reduced?
• Will the stone-free status be affected? The researchers will compare the fluoroscopic control intervals of 250 shocks and 500 shocks.

Participants will:

• Take to a maximum of 3 sessions.
• Check once a week
• Group 1 was fluoroscopically monitored every 250 shocks, and Group 2 was fluoroscopically monitored every 500 shocks

Full description

SWL works on the principle of focusing on the calculus using ultrasonography or fluoroscopy, transmitting high-energy shock waves from the lithotripter to the calculus and fragmenting it. Fluoroscopic focusing is a commonly used imaging technique that raises concerns about ionizing radiation exposure for patients, technologists, and physicians. Intermittent fluoroscopic monitoring during SWL is widely employed to adjust for patient movement, respiratory movement, and stone displacement within the kidney. However, there is no consensus on the optimal frequency of fluoroscopic monitoring in the literature. This study aims to seek to determine whether increasing the duration between fluoroscopic checks affects the success rate of SWL in achieving stone-free status while reducing radiation exposure to patients.

Enrollment: 158 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• radiopaque renal pelvic stones smaller than 2 centimeters.

Exclusion criteria

• anatomical anomalies, coagulation disorders, non-opaque calculi, active urinary infection and distal obstruction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

250 shocks

Active Comparator group

Description:

In our clinic, it is standard practice to perform a fluoroscopic check after every 250 shocks during the SWL session. Group 1 was fluoroscopically monitored every 250 shocks.

Treatment:

Device: Shock wave lithotripsy

500 shocks

Active Comparator group

Description:

Group 2 was fluoroscopically monitored every 500 shocks.

Treatment:

Device: Shock wave lithotripsy