Escalating, Constant and Reduction Energy Output in SWL for Renal Stones

NCT ID: NCT02037906

Last Updated: 2016-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-03-31

Brief Summary

Research Problem: Shock wave lithotripsy (SWL) dramatically changed the management of renal and ureteral calculus disease. In vitro studies suggest that progressive increase in lithotripter energy output voltage could produce the best overall stone comminution in comparison with constant or deescalating energy output. However, it is possible that the beneficial impact of slow rate SWL on comminution of stones and stone free rates has masked any marginal benefits for energy output escalation. The Escalating SW method adds the benefit of less renal tissue injury.

Research Significance:The present study will signifies and evaluates the stone free rates of three groups of patients with renal stones treated with different SWL energy outputs (Escalating, Constant and Reduction energy output).

Research Objectives: The aim of this research project is to study the effect of dose adjustment strategies on success rate of Shock Wave Lithotripsy in the clinical setting and to optimize the conditions for successful Shock Wave Lithotripsy.

Research Methodology: This clinical trial will be conducted at a tertiary care university hospital. 150 patients referred to the Shock wave lithotripsy unit will be evaluated for eligibility to be randomized into three groups (Dose Escalation, Dose reduction and constant dose). Parameter of the three groups will be compared to detect the treatment difference.

Detailed Description

Escalating SW amplitude treatment protocols have been shown to be safe on long-term with less harm to kidney tissue. This clinical trial will be conducted at a tertiary care university hospital. All patients referred to the SWL unit will be evaluated for eligibility to be randomized. Randomization process "complete" or "unrestricted" randomization was used to allocate patients to the three arms of the clinical trial where one patient was randomly assigned to one of the three arms blindly.

Conditions

Renal Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Escalating Energy SWL

50 Patients

Group Type: EXPERIMENTAL

Escalating Energy SWL

Intervention Type: RADIATION

Dose escalation, 1500 SW at 18 kv, followed by 1500 SW at 20 kv and the following 1500 SW at 22 kv.

Constant Energy SWL

50 Patients

Group Type: EXPERIMENTAL

Constant Energy SWL

Intervention Type: RADIATION

Constant dose at 20 kv

Reduction Energy SWL

50 Patients

Group Type: EXPERIMENTAL

Reduction Energy SWL

Intervention Type: RADIATION

Dose reduction, 1500 SW at 22 kv, followed by 1500 SW at 20 kv and the following at 18 kv.

Interventions

Escalating Energy SWL

Dose escalation, 1500 SW at 18 kv, followed by 1500 SW at 20 kv and the following 1500 SW at 22 kv.

Intervention Type: RADIATION

Constant Energy SWL

Constant dose at 20 kv

Intervention Type: RADIATION

Reduction Energy SWL

Dose reduction, 1500 SW at 22 kv, followed by 1500 SW at 20 kv and the following at 18 kv.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Single stone
• Radio opaque
• Less than 2cm in size
• Renal stone

Exclusion Criteria

• bleeding disorder,
• urinary tract infection (UTI)
• distal ureteric obstruction

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Al-Johara Al-Ibrahim Cancer Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danny M Rabah, Professor

Role: PRINCIPAL_INVESTIGATOR

College Of Medicine, King Saud University

Locations

King Khalid University Hospital

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

13/3948/IRB

Identifier Type: REGISTRY

Identifier Source: secondary_id

13/3948/IRB

Identifier Type: -

Identifier Source: org_study_id