Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

Last updated: January 22, 2025
Sponsor: Indiana Kidney Stone Institute
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hyperparathyroidism

Kidney Stones

Treatment

videotape for mapping of renal anatomy and papillary biopsy

Clinical Study ID

NCT00169806
98-073
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of Methodist Urology in Indianapolis, IN who are undergoing endoscopicprocedures 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

Exclusion Criteria:

  • Poor general medical health

  • Bleeding diathesis

  • Inability or unwillingness to comply with post-surgical follow-up

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: videotape for mapping of renal anatomy and papillary biopsy
Phase:
Study Start date:
November 01, 1998
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • IU Health North Hospital

    Indianapolis, Indiana 46032
    United States

    Site Not Available

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