Database and Registry for Renal Diverticulum

NCT ID: NCT00169715

Last Updated: 2008-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2007-04-30

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.

Conditions

Kidney Stones; Renal Calculi; Tic

Keywords

Kidney stones; renal Calculi; Tic; Caliceal Diverticula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

A

Group Type: OTHER

Percutaneous Caliceal Diverticuli

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: collaborator

Indiana Kidney Stone Institute

OTHER

Sponsor Role: lead

Responsible Party

Methodist Urology, Indiana Kidney Stone Instititue

Principal Investigators

James E Lingeman, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist Urology, LLC

Locations

Methodist Hospital

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 15758742 (View on PubMed)

Other Identifiers

03-019

Identifier Type: -

Identifier Source: org_study_id