Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

Pediatric Urinary Lithiasis Clinical Trial

Official title:

STEPWISE SHOCK WAVE LITHOTRIPSY IN PEDIATRIC UROLITHIASIS: A COMPARATIVE STUDY.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807260
• Other study ID #: stepwise0946
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: March 6, 2013
• Start date: March 2008
• Est. completion date: June 2012

Study information

• Verified date: March 2013
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To evaluate and compare the results of conventional and stepwise shock wave lithotripsy treatment modalities in pediatric urinary lithiasis.

Description:

Between March 2008 and February 2012, 81 patients were randomized and included in this study. Shock wave lithotripsy was performed by using a Dornier Compact Delta instrument. Localizations of radiopaque and non-opaque stones were estimated by using flouroscopy and ultrasonography, respectively. Treatment energy was set on 13 kV in the conventional group. In the stepwise group, treatment energy was initially set on 10 kV and gradually increased up to 13 kV per 250 shocks. The maximum numbers of shocks in both groups were limited to 3000. Patients were followed up with 15 days interval. In each visit, patients were respectively questioned for pain, hematuria and history of stone passage. In case of treatment failure, shock wave lithotripsy was repeated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 16 Years

Eligibility

Inclusion Criteria:

The patients with pediatric urinary lithiasis.

Exclusion Criteria:

Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pediatric Urinary Lithiasis
• Urolithiasis

Intervention

Procedure:
• Shock wave lithotripsy
All procedures were performed under continuous intravenous sedo-analgesia (using a combination of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave lithotrpisy was poerformed with a Dornier Compact Delta lithotripter (Dornier Medtech, Germany). Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiplying the largest length and width of the individual stones measured from the abdominal plain X-ray.

Locations

Country	Name	City	State
Turkey	Department of Urology, Erciyes University Medical Faculty,	Kayseri	Talas

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Demirci D, Altiok E, Gülmez I, Ekmekçioglu O, Poyrazoglu HM. Stepwise shock wave lithotripsy: results of initial study for the treatment of urinary stones in childhood. Int Urol Nephrol. 2006;38(2):189-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Degree and presence of hydronephrosis.	To detect obstruction in the system, ultrasonography was used during control.	Three months	Yes
Other	Stone burden on spiral computed tomography	In case of non-opaque Stones, stone borden was evalusted with spinal computed tomography. Clinical success was considered if the residual fragments were 2-3 mm or less in asymptomatic patients.	Three months	Yes
Primary	Stone burden on plain X-ray.	The stone burden was defined as the stone area that was calculated by multiplying the largest length(cm)and width (cm)of the individual stones measured from the abdominal plain X-ray. To detect fragmentation of the stone and necessity of re-treatment a plain film were used during control. Stone clearance was assessed at three months. Stone-free state was defined as the absence of stone fragments on a good quality plain X-ray. Clinical success was considered if the residual fragments were 2-3 mm or less in asymptomatic patients.	Three months.	Yes