Attached Stone Project: Do Calcium Oxalate Renal Calculi Originate From Randall's Plaque?
Urolithiasis is a common condition in the United States, and is associated with significant morbidity and even mortality. The most commonly occurring urinary calculi are comprised of calcium oxalate salts, and until recently, the pathogenesis of calcium oxalate calculi was poorly understood. New evidence, however, suggests that the development of calcium oxalate calculi may be intimately associated with hydroxyapatite (HA) plaque, also known as Randall's plaque, which is located on the renal papillae. The investigators have previously demonstrated that Randall's plaque originates in the thin ascending limb of the loop of Henle, and they have shown that Randall's plaque is composed of HA (Evan, Lingeman et al. 2003). As well, the amount of Randall's plaque correlates with elevated levels of urinary calcium and decreased urinary volume, risk factors for the formation of calcium oxalate calculi (Kuo, Lingeman et al. 2003). In the course of these previous studies, the investigators have anecdotally noted that calcium oxalate stones are often found attached to Randall's plaque, an observation that others have reported as well (Prien 1949; Carr 1954; Cifuentes Delatte, Minon-Cifuentes et al. 1987). However, there has been no in-vivo, rigorous documentation of this "attached stone" relationship. Attached calculi represent an important point in the pathogenesis of calcium oxalate calculi, as they correspond to a moment in time where there is a continuum between the HA plaque of Randall and the calcium oxalate stone, thus linking the origin of plaque with the development of stone. A better understanding of the phenomenon of attached calculi will lead to a better understanding of how and why calcium oxalate stones form, which may ultimately direct future interventions to attenuate stone activity.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Do Calcium Oxalate Renal Calculi Originate From Randall's Plaque?|
- Detailed analysis of all stones from common calcium oxalate stone formers to determine stone composition and the site of stone attachment [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
mapping and data collection
Other: mapping kidney anatomy
videotape of surgical procedure to document location of attached stones and condition of calyces and papilla.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169754
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||James E Lingeman, MD||Methodist Urology, LLC|