Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169663
Status:
COMPLETED
Last Update Posted:
2012-04-24
First Post:
2005-09-09
Brief Title:
Brushite Kidney Stones A Registry and Database of Clinical and Laboratory Findings
Sponsor:
Indiana Kidney Stone Institute
Organization:
Indiana Kidney Stone Institute
Study Overview
Official Title:
Brushite Stones A Registry and Database of Clinical and Laboratory Findings
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brushite kidney stones are a unique form of calcium phosphate stones that have a tendency to recur quickly if patients are not aggressively treated with stone prevention measures Little research has been undertaken to better understand the clinical history and potential urinary abnormalities that may predispose one to these troublesome kidney stones
Detailed Description:
Multiple treatment options are available for the treatment of kidney or ureteral calculi Treatment options include shock wave lithotripsy SWL shock waves are transmitted through the body wall and focused onto the stone to break the stone into gravel percutaneous nephrolithotomy PNL a small flank incision is made and a telescope inserted into the kidney to allow stone fragmentation and removal from the patient and ureteroscopic lithotripsy URS a small telescope is inserted into the ureter or kidney and a laser is used to break up the stone into gravel
Brushite is a unique form of calcium phosphate kidney stone that often has sub-optimal stone fragmentation with shock wave lithotripsy Heimbach et al 1999 Due to its SWL resistance brushite patients often undergo more invasive treatments such as URS or PNL to achieve a stone free status Brushite patients often have multiple stones and have a high likelihood of developing recurrences new stone formation or regrowth of existing stone fragments often within the first year after surgery These patients may also have a history of anatomical abnormalities of the urinary tract or a history of prior renal or ureteral surgery Klee et al 1991
A thorough review of the clinical radiological and metabolic data of brushite patients has the potential to clarify a number of important points Many patients with brushite stones often have a history of non-brushite stones eg calcium oxalate predating the development of brushite stones and historical review is needed to define the factors contributing to this shift in stone composition In addition it has been shown that CT attenuation values can be used to predict stone composition Joseph et al 2002 As a result it is crucial to review the radiologic appearance of known brushite stones to identify specific radiographic characteristics and possibly allow a radiographic diagnosis of brushite to be established Finally very little information has been reported on the urinary abnormalities in brushite patients By carefully examining 24 hour urine data in a large population of brushite patients information may be identified that can be used to provide improved management of specific abnormalities to prevent stone recurrences
Brushite is a unique form of calcium phosphate kidney stone that often has sub-optimal stone fragmentation with shock wave lithotripsy Heimbach et al 1999 Due to its SWL resistance brushite patients often undergo more invasive treatments such as URS or PNL to achieve a stone free status Brushite patients often have multiple stones and have a high likelihood of developing recurrences new stone formation or regrowth of existing stone fragments often within the first year after surgery These patients may also have a history of anatomical abnormalities of the urinary tract or a history of prior renal or ureteral surgery Klee et al 1991
A thorough review of the clinical radiological and metabolic data of brushite patients has the potential to clarify a number of important points Many patients with brushite stones often have a history of non-brushite stones eg calcium oxalate predating the development of brushite stones and historical review is needed to define the factors contributing to this shift in stone composition In addition it has been shown that CT attenuation values can be used to predict stone composition Joseph et al 2002 As a result it is crucial to review the radiologic appearance of known brushite stones to identify specific radiographic characteristics and possibly allow a radiographic diagnosis of brushite to be established Finally very little information has been reported on the urinary abnormalities in brushite patients By carefully examining 24 hour urine data in a large population of brushite patients information may be identified that can be used to provide improved management of specific abnormalities to prevent stone recurrences
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None