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| Descriptive Information Fields | |||||
| Brief Title † | Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis | ||||
| Official Title † | Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis | ||||
| Brief Summary | Kidney stones are very common. They affect 3-5% of the population in the United States. Many people are hospitalized for the treatment of kidney stones and some may die. Better understanding of what causes kidney stones is useful in both the treatment and prevention of kidney stones. However, exactly what causes kidney stones is unknown. The most common type of kidney stones contains calcium, which sometimes is attached to a part of the kidney important in producing the final urine, called the papilla. The investigators have noticed that persons who form kidney stones seem to have more papilla with stones attached. They propose to study these areas of the papilla, called Randall's plaques (named after their discoverer), in patients undergoing surgery for kidney stones. |
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| Detailed Description | In order to attempt to explain the pathogenesis of renal calculi, the investigators videotape and document the location and characteristics of each stone, papillae and calyces. One or more small papillary biopsies are taken for analysis to help determine the point of origin of the kidney stone and histological studies are undertaken to determine tissue differences amongst different types of stone formers. Approximately one month after surgery, metabolic studies are undertaken to further review potential causes of stone formation. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment | ||||
| Primary Outcome Measure † | To find out why people form stones by comparing 24 urine collections, biopsy and anatomy to other patients who do not form stones and other patients who do form stones to see if the differences are significant [ Time Frame: One year from study completion ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Nephrocalcinosis Renal Calculi Hypercalciuria Hyperparathyroidism Cystinuria |
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| Intervention † | Other: videotape for mapping of renal anatomy and papillary biopsy | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 200 | ||||
| Start Date † | November 1998 | ||||
| Completion Date | December 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00169806 | ||||
| Organization ID | 98-073 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Indiana Kidney Stone Institute | ||||
| Collaborators †† | Indiana University School of Medicine University of Chicago |
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| Investigators † |
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| Information Provided By | Indiana Kidney Stone Institute | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | May 5, 2008 | ||||
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