Clinical trial NCT00169806: Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis
Official title: Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nephrocalcinosis
Renal Calculi
Hypercalciuria
Hyperparathyroidism
Cystinuria
Keywords: Randall's Plaque
Kidney stones
Lead sponsor: Indiana Kidney Stone Institute
Sponsor class: OTHER
Collaborators: name: Indiana University School of Medicine
name: University of Chicago
First posted: 2005-09-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: One year from study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health North Hospital
state: Indiana
Study officials:
affiliation: IU Health Physicians Urology
name: James Lingeman, MD
role: PRINCIPAL_INVESTIGATOR
References: