Kidney Stone Structural Analysis By Helical Computed Tomography (CT)

NCT00169780 | Completed

• 1 other identifier: 02-035
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Current practices of the diagnosis of urinary stones gives little information on the probable fragility of stones using shock wave lithotripsy (SWL), and many patients receive more SW's than is necessary to break up their stones. Indeed, some patients are treated with SWL when their stones cannot be fragmented using this technology. The investigators have ample evidence that computed tomography (CT) images of kidney stones can reveal significant internal structure in stones-structure that is likely to be useful in predicting stone fragility-but no one has explored the use of clinical helical CT for this purpose. Also, the investigators do not know the effect that the human body wall and kidney tissue will have on the resolution of kidney stone structure with helical CT.

Conditions

Nephrolithiasis

Keywords

Renal Calculi; Radiology; High Reslolution CT

Outcome Measures

Primary Outcomes (1)

• To determine whether available clinical helical CT is able to reveal internal structure of kidney stones

  Post op day one

Secondary Outcomes (1)

• To determine if high resolution CT can differentiate between plaque and renal calculi.

  Post op day one

Study Arms (1)

cohort

patients who require a CT scan prior to kidney stone surgery for diagnostic purposes

Radiation: High definition helical CT (64 head scanner)

Interventions

High definition helical CT (64 head scanner) RADIATION

Patients who require a CT scan for diagnostic purposes prior to kidney stone surgery will undergo a high definition helical CT rather than the standard CT scan. This high resolution scan will then be reviewed by the researchers to help determine the type of treatment needed for the kidney stone removal. The aim is to see if the higher resolution will show more of the stone "anatomy" which will help the surgeon determine if the stone will be amenable to shock wave lithotripsy or if another type of treatment would best serve the patient needs.

cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of Methodist Urology, Indianapolis, Indiana who require a CT scan prior to percutaneous removal of renal calculi.

You may qualify if:

• Male and female kidney stone patients of IU Health Physicians Urology in Indianapolis, IN requiring a computed tomography scan prior to their stone surgical treatment (extracorporeal shock wave lithotripsy \[ESWL\], percutaneous nephrolithotomy, ureteroscopy)
• Eligible patients must be able to suspend respiration for at least 20 seconds. The patient will be asked to perform a respiration suspension test for 20 seconds before recruitment.

You may not qualify if:

• Women in whom the potential for pregnancy has not been excluded are not eligible. A pregnancy test will be performed if necessary.
• Inability to give informed consent
• A previous history of abdominal malignancy

Sponsors & Collaborators

• Indiana Kidney Stone Institute: lead
• Indiana University School of Medicine: collaborator
• National Kidney Foundation, United States: collaborator

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• James Lingeman, MD

  IU Health Physicians Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2002
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 7, 2011

Record last verified: 2011-12

Locations

US (1)