Database and Registry for Renal Diverticulum

NCT00169715 | Completed

• 1 other identifier: 03-019
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Historically, percutaneous treatment of stone-bearing caliceal diverticula has resulted in the best success rates when examining factors such as symptom relief and stone-free rates (Jones, et al, 1991). Many groups have reported modifications in their percutaneous approach which have reportedly improved patient outcomes, but these series have very limited populations. Another issue concerning stone-bearing caliceal diverticula centers on the etiology of stones formation within these areas. This topic remains a subject of debate, with conflicting data in the literature.

Conditions

Kidney Stones; Renal Calculi; Tic

Keywords

Kidney stones; renal Calculi; Tic; Caliceal Diverticula

Outcome Measures

Primary Outcomes (1)

• We hope to use the urine metabolic data to clarify whether this subset of stone forming patients have significant underlying metabolic risk factors that contribute to stone formation within their diverticula.

  Two months post-op

Study Arms (1)

A

OTHER

Procedure: Percutaneous Caliceal Diverticuli

Interventions

Percutaneous Caliceal Diverticuli PROCEDURE

Standard of care to remove a stone from a caliceal diverticulum is to do a percutaneous procedure for stone removal and then fulgerate the diverticulum to prevent stone recurrence. We plan to aspirate urine from this diverticulum and compare it to urine collected from the renal pelvis of the same kidney.

A

Eligibility Criteria

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

You may qualify if:

• \. Male or female patients over the age of 18 with symptomatic caliceal diverticular stone(s) who have had or require percutaneous treatment

You may not qualify if:

• Patients unable to give informed consent
• Patients with active bleeding diatheses
• Women who are pregnant or in whom pregnancy status cannot be confirmed
• Patients with renal insufficiency requiring dialysis
• Patients with a baseline serum creatinine of 1.4 or greater

Sponsors & Collaborators

• Indiana Kidney Stone Institute: lead
• University of Chicago: collaborator

Study Sites (1)

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Kim SC, Kuo RL, Tinmouth WW, Watkins S, Lingeman JE. Percutaneous nephrolithotomy for caliceal diverticular calculi: a novel single stage approach. J Urol. 2005 Apr;173(4):1194-8. doi: 10.1097/01.ju.0000152320.41995.c2.

  PMID: 15758742 RESULT

MeSH Terms

Conditions

Kidney Calculi; Tics

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• James E Lingeman, MD

  Methodist Urology, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: February 1, 2003
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: September 18, 2008

Record last verified: 2008-09

Locations

US (1)