Database and Registry for Renal Diverticulum
Primary Purpose
Kidney Stones, Renal Calculi, Tic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Caliceal Diverticuli
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Stones focused on measuring Kidney stones, renal Calculi, Tic, Caliceal Diverticula
Eligibility 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: 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
Sites / Locations
- Methodist Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A
Arm Description
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00169715
First Posted
September 9, 2005
Last Updated
September 16, 2008
Sponsor
Indiana Kidney Stone Institute
Collaborators
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00169715
Brief Title
Database and Registry for Renal Diverticulum
Official Title
Percutaneous Surgical Outcomes and Metabolic Findings in Patients With Stone-Bearing Calicial Diverticula
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Indiana Kidney Stone Institute
Collaborators
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones, Renal Calculi, Tic
Keywords
Kidney stones, renal Calculi, Tic, Caliceal Diverticula
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Caliceal Diverticuli
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E Lingeman, MD
Organizational Affiliation
Methodist Urology, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15758742
Citation
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.
Results Reference
result
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Database and Registry for Renal Diverticulum
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