Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis
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Purpose
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 |
|---|---|
|
Nephrocalcinosis Renal Calculi Hypercalciuria Hyperparathyroidism Cystinuria |
Other: videotape for mapping of renal anatomy and papillary biopsy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis |
- 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 ]
| Estimated Enrollment: | 400 |
| Study Start Date: | November 1998 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
cohort
Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients of Methodist Urology in Indianapolis, IN who are undergoing endoscopic procedures for nephrolithiasis or other urologic disease.
- Upper urinary tract endoscopic or PERC procedure for kidney stones removal
- General medical health allowing surgical procedure
- Ability to complete all the necessary components of the study
- Able to sign an informed consent
Exclusion Criteria:
- Poor general medical health
- Bleeding diathesis
- Inability or unwillingness to comply with post-surgical follow-up
Contacts and Locations| Contact: Lori Rawlings, RN | 317-962-0870 | lrawlings@iuhealth.org |
| United States, Indiana | |
| IU Health Methodist Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Lori Rawlings, RN 317-962-0870 lrawlings@iuhealth.org | |
| Principal Investigator: James Lingeman, MD | |
| Principal Investigator: | James Lingeman, MD | IU Health Physicians Urology |
More Information
No publications provided
| Responsible Party: | Indiana Kidney Stone Institute |
| ClinicalTrials.gov Identifier: | NCT00169806 History of Changes |
| Other Study ID Numbers: | 98-073 |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana Kidney Stone Institute:
|
Randall's Plaque Kidney stones |
Additional relevant MeSH terms:
|
Renal Aminoacidurias Calculi Cystinuria Hypercalciuria Hyperparathyroidism Kidney Calculi Nephrocalcinosis Nephrolithiasis Pathological Conditions, Anatomical Renal Tubular Transport, Inborn Errors Kidney Diseases Urologic Diseases |
Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Urological Manifestations Signs and Symptoms Parathyroid Diseases Endocrine System Diseases Urolithiasis Urinary Calculi Calcinosis Calcium Metabolism Disorders |
ClinicalTrials.gov processed this record on May 23, 2013