Attached Stone Project: Do Calcium Oxalate Renal Calculi Originate From Randall's Plaque?

NCT00169754 | Completed

• 1 other identifier: 05-031
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Calculi

Keywords

Nephrolithiasis; Renal Calculi; Perc; Attached Stones

Outcome Measures

Primary Outcomes (1)

• Detailed analysis of all stones from common calcium oxalate stone formers to determine stone composition and the site of stone attachment

  one year

Study Arms (1)

cohort

OTHER

mapping and data collection

Other: mapping kidney anatomy

Interventions

mapping kidney anatomy OTHER

videotape of surgical procedure to document location of attached stones and condition of calyces and papilla.

cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients of Methodist Urology in Indianapolis, IN with kidney stones appropriate for percutaneous lithotripsy (PERC)
• Age greater than 18 years

You may not qualify if:

• Inability to give informed consent
• Active infection
• Bleeding diathesis
• Pregnancy

Sponsors & Collaborators

• Indiana Kidney Stone Institute: lead
• Indiana University School of Medicine: collaborator

Study Sites (1)

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• James E Lingeman, MD

  Methodist Urology, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: April 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: September 17, 2008

Record last verified: 2008-09

Locations

US (1)