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Sponsors and Collaborators: |
Indiana Kidney Stone Institute Indiana University School of Medicine University of Chicago |
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Information provided by: | Indiana Kidney Stone Institute |
ClinicalTrials.gov Identifier: | NCT00169806 |
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.
Condition | Intervention |
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Nephrocalcinosis Renal Calculi Hypercalciuria Hyperparathyroidism Cystinuria |
Other: videotape for mapping of renal anatomy and papillary biopsy |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis |
Estimated Enrollment: | 200 |
Study Start Date: | November 1998 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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cohort
Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities
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Other: videotape for mapping of renal anatomy and papillary biopsy
Subjects who enroll in this study will have their renal anatomy videotaped for mapping purposes. Stone location and characteristics will be documented as will papilla and calyces. One or more papillary biopsies will be taken for analysis.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shelly E Handa, RN | 317-962-0870 | shanda@clarian.org |
United States, Indiana | |
Methodist Hospital | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Shelly E Handa, RN 317-962-0870 shanda@clarian.org | |
Principal Investigator: James Lingeman, MD | |
Sub-Investigator: Larry Munch, MD |
Principal Investigator: | James Lingeman, MD | Methodist Urology, LLC |
Responsible Party: | Methodist Urology ( James Lingeman, MD ) |
Study ID Numbers: | 98-073 |
Study First Received: | September 12, 2005 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00169806 |
Health Authority: | United States: Institutional Review Board |
Randall's Plaque Kidney stones |
Pathological Conditions, Anatomical Urinary Calculi Parathyroid Diseases Metabolic Diseases Cystinuria Urolithiasis Endocrine System Diseases Calculi Calcinosis Metabolism, Inborn Errors Signs and Symptoms |
Hyperparathyroidism Urologic Diseases Genetic Diseases, Inborn Hypercalciuria Endocrinopathy Kidney Diseases Metabolic disorder Nephrolithiasis Nephrocalcinosis Kidney Calculi |
Calcium Metabolism Disorders Urological Manifestations Renal Aminoacidurias Renal Tubular Transport, Inborn Errors |