Database and Registry for Renal Diverticulum

Kidney Stones Clinical Trial

Official title:

Percutaneous Surgical Outcomes and Metabolic Findings in Patients With Stone-Bearing Calicial Diverticula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169715
• Other study ID #: 03-019
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: September 16, 2008
• Start date: February 2003
• Est. completion date: April 2007

Study information

• Verified date: September 2008
• Source: Indiana Kidney Stone Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Calculi
• Diverticulum
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Renal Calculi
• Tic

Intervention

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.

Locations

Country	Name	City	State
United States	Methodist Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana Kidney Stone Institute	University of Chicago

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No