Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169715
Status:
COMPLETED
Last Update Posted:
2008-09-18
First Post:
2005-09-09
Brief Title:
Database and Registry for Renal Diverticulum
Sponsor:
Indiana Kidney Stone Institute
Organization:
Indiana Kidney Stone Institute
Study Overview
Official Title:
Percutaneous Surgical Outcomes and Metabolic Findings in Patients With Stone-Bearing Calicial Diverticula
Status:
COMPLETED
Status Verified Date:
2008-09
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:
Historically percutaneous treatment of stone-bearing caliceal diverticula has resulted in the best success rates when examining factors such as symptom relief and stone-free rates Jones et al 1991 Many groups have reported modifications in their percutaneous approach which have reportedly improved patient outcomes but these series have very limited populations Another issue concerning stone-bearing caliceal diverticula centers on the etiology of stones formation within these areas This topic remains a subject of debate with conflicting data in the literature
Detailed Description:
Caliceal diverticula are non-secretory cavities which are connected to the remainder of the renal collecting system through narrow infundibulae Calculi are associated with these cavities from 95 to 78 of cases Liatsikos et al 2000 Monga et al 2000 This subset of stone-forming patients often presents with recurrent urinary tract infections and flank discomfort The definitive treatment for this entity remains surgical with shock wave lithotripsy SWL ureteroscopy URS percutaneous nephrolithotomy PNL and laparoscopy all serving as management options However multiple groups have demonstrated that PNL remains the treatment modality of choice secondary to its superior stone-free and symptom relief rates Jones et al 1991 Donnellan et al 1999 Shalhav et al 1998 Over time technique modifications have been reported by other groups Monga et al 2000 Auge et al 2002 involving different methods of managing the infundibulum that connects the diverticulum to the rest of the renal collecting system Our own surgical experience with percutaneous treatment of stone-bearing caliceal diverticula has resulted in various technique modifications as well which we believe have continued to improve patient outcomes To support our hypothesis we will need to perform a systematic review our patient population to document these surgical outcomes
Another question surrounding this subset of patients involves the primary factor responsible for the formation of calculi within the diverticula Unfortunately the literature has provided conflicting data on this issue Some groups attribute stone formation to underlying metabolic abnormalities Hsu et al 1998 Other groups have not found any metabolic problems instead concluding that impaired urinary drainage from the diverticulum primarily contributes calculus formation Liatsikos et al 2000 By prospectively obtaining urines on our caliceal diverticula patients we hope that detailed metabolic analyses will allow us to conclude definitively whether metabolic abnormalities are prevalent in this population
Another question surrounding this subset of patients involves the primary factor responsible for the formation of calculi within the diverticula Unfortunately the literature has provided conflicting data on this issue Some groups attribute stone formation to underlying metabolic abnormalities Hsu et al 1998 Other groups have not found any metabolic problems instead concluding that impaired urinary drainage from the diverticulum primarily contributes calculus formation Liatsikos et al 2000 By prospectively obtaining urines on our caliceal diverticula patients we hope that detailed metabolic analyses will allow us to conclude definitively whether metabolic abnormalities are prevalent in this population
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