Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

Sponsor

Indiana Kidney Stone Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT00169806

Collaborator

Indiana University School of Medicine (Other), University of Chicago (Other)

600

Enrollment

Location

Arm

325

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrocalcinosis Renal Calculi Hypercalciuria Hyperparathyroidism Cystinuria	Other: videotape for mapping of renal anatomy and papillary biopsy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis

Study Start Date :

Nov 1, 1998

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

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 [One year from study completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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