Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

August 3, 2009

Start Date ^ICMJE

November 1998

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To find out why people form stones by comparing 24 urine collections, biopsy and anatomy to other patients that do not form stones and other patients that do form stones to see if the differences are significant.

Change History

Complete list of historical versions of study NCT00169806 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

Official Title ^ICMJE

Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Nephrocalcinosis
Renal Calculi
Hypercalciuria
Hyperparathyroidism
Cystinuria

Intervention ^ICMJE

Other: videotape for mapping of renal anatomy and papillary biopsy

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Shelly E Handa, RN

317-962-0870

shanda@clarian.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00169806

Responsible Party

James Lingeman, MD, Methodist Urology

Study ID Numbers ^ICMJE

98-073

Study Sponsor ^ICMJE

Indiana Kidney Stone Institute

Collaborators ^ICMJE

Indiana University School of Medicine
University of Chicago

Investigators ^ICMJE

Principal Investigator:

James Lingeman, MD

Methodist Urology, LLC

Information Provided By

Indiana Kidney Stone Institute

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP