Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

NCT ID: NCT00169806

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-11-30
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Nephrocalcinosis; Renal Calculi; Hypercalciuria; Hyperparathyroidism; Cystinuria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

cohort

Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities

Group Type: OTHER

videotape for mapping of renal anatomy and papillary biopsy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University School of Medicine

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

Indiana Kidney Stone Institute

OTHER

Sponsor Role: lead

Responsible Party

James Lingeman

James Lingeman, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Lingeman, MD

Role: PRINCIPAL_INVESTIGATOR

IU Health Physicians Urology

Locations

IU Health North Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

98-073

Identifier Type: -

Identifier Source: org_study_id