Database and Registry for Renal Diverticulum

This study has been completed.
Sponsor:
Collaborator:
University of Chicago
Information provided by:
Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:
NCT00169715
First received: September 9, 2005
Last updated: September 16, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
Kidney Stones
Renal Calculi
Tic
Procedure: Percutaneous Caliceal Diverticuli

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Percutaneous Surgical Outcomes and Metabolic Findings in Patients With Stone-Bearing Calicial Diverticula

Resource links provided by NLM:


Further study details as provided by Indiana Kidney Stone Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: Two months post-op ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: February 2003
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A Procedure: Percutaneous Caliceal Diverticuli
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.

Detailed Description:

Caliceal diverticula are non-secretory cavities which are connected to the remainder of the renal collecting system through narrow infundibulae. Calculi are associated with these cavities from 9.5 to 78% of cases (Liatsikos, et al 2000; Monga, et al 2000). This subset of stone-forming patients often presents with recurrent urinary tract infections and flank discomfort. The definitive treatment for this entity remains surgical, with shock wave lithotripsy (SWL), ureteroscopy (URS), percutaneous nephrolithotomy (PNL), and laparoscopy all serving as management options. However, multiple groups have demonstrated that PNL remains the treatment modality of choice secondary to its superior stone-free and symptom relief rates (Jones, et al 1991; Donnellan, et al 1999; Shalhav, et al 1998). Over time, technique modifications have been reported by other groups (Monga, et al 2000; Auge, et al 2002) involving different methods of managing the infundibulum that connects the diverticulum to the rest of the renal collecting system. Our own surgical experience with percutaneous treatment of stone-bearing caliceal diverticula has resulted in various technique modifications as well, which we believe have continued to improve patient outcomes. To support our hypothesis, we will need to perform a systematic review our patient population to document these surgical outcomes.

Another question surrounding this subset of patients involves the primary factor responsible for the formation of calculi within the diverticula. Unfortunately, the literature has provided conflicting data on this issue. Some groups attribute stone formation to underlying metabolic abnormalities (Hsu, et al 1998). Other groups have not found any metabolic problems, instead concluding that impaired urinary drainage from the diverticulum primarily contributes calculus formation (Liatsikos, et al 2000). By prospectively obtaining urines on our caliceal diverticula patients, we hope that detailed metabolic analyses will allow us to conclude definitively whether metabolic abnormalities are prevalent in this population.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

  1. Patients unable to give informed consent
  2. Patients with active bleeding diatheses
  3. Women who are pregnant or in whom pregnancy status cannot be confirmed
  4. Patients with renal insufficiency requiring dialysis
  5. Patients with a baseline serum creatinine of 1.4 or greater
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00169715

Locations
United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana Kidney Stone Institute
University of Chicago
Investigators
Principal Investigator: James E Lingeman, MD Methodist Urology, LLC
  More Information

Additional Information:
Publications:
Responsible Party: James Lingeman, M.D., Methodist Urology, Indiana Kidney Stone Instititue
ClinicalTrials.gov Identifier: NCT00169715     History of Changes
Other Study ID Numbers: 03-019
Study First Received: September 9, 2005
Last Updated: September 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana Kidney Stone Institute:
Kidney stones
renal Calculi
Tic
Caliceal Diverticula

Additional relevant MeSH terms:
Calculi
Diverticulum
Kidney Calculi
Nephrolithiasis
Tics
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014