- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00169715
Database and Registry for Renal Diverticulum
Percutaneous Surgical Outcomes and Metabolic Findings in Patients With Stone-Bearing Calicial Diverticula
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Methodist Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: A
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Two months post-op
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-019
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