Fluoroscopy Activation Interval in SWL

Comparison of Two Different Fluoroscopy Activation Intervals in Shock Wave Lithotripsy: a Prospective Randomised Study

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

Study Overview

• Status: Completed
• Conditions: Kidney Calculi
• Intervention / Treatment: Device: Shock wave lithotripsy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • Health Science University Kartal Dr. Lütfi Kırdar City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 250 shocks; 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.	Device: Shock wave lithotripsy; SWL works on the principle of focusing on the calculus using fluoroscopy. There has yet to be a consensus on the optimal frequency of fluoroscopic monitoring in the literature.
Active Comparator: 500 shocks; Group 2 was fluoroscopically monitored every 500 shocks.	Device: Shock wave lithotripsy; SWL works on the principle of focusing on the calculus using fluoroscopy. There has yet to be a consensus on the optimal frequency of fluoroscopic monitoring in the literature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate The effect of two different fluoroscopic activation intervals on the stone-free rate.	Session intervals were determined as one week, and patients with residues visible on the KUB radiography before the session were included in the new session. At the end of the treatment, direct radiography and ultrasound of the urinary system was performed at the end of the first month. Patients with stones larger than 4 mm were considered to have had an unsuccessful treatment.	1 month after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoints were total fluoroscopy time and complications.	The total fluoroscopy time (seconds) during treatment will be calculated.	From registration until the 1st month after the end of treatment.
Secondary endpoints were complications.	Complications occurring from the beginning of treatment to the end of treatment, such as additional intervention, pyelonephritis, steinstrausse.	From registration until the 1st month after the end of treatment.

Collaborators and Investigators

• Sponsor: Lütfi Kırdar City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: November 9, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Estimated): November 14, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: radiation; kidney stone; shock wave lithotripsy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Kidney Calculi; Nephrolithiasis; Calculi
• Other Study ID Numbers: Canakci0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No