Kidney StonesNCT00169715
Database and Registry for Renal Diverticulum
A study testing Percutaneous Caliceal Diverticuli in people with Kidney Stones and Renal Calculi, run by Indiana Kidney Stone Institute at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones, Renal Calculi, Tic
- What is being tested?
- Percutaneous Caliceal Diverticuli
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female patients over the age of 18 with symptomatic caliceal diverticular stone(s) who have had or require percutaneous treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Surgical Outcomes and Metabolic Findings in Patients With Stone-Bearing Calicial Diverticula
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.
Read the 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
- Being tested
- Percutaneous Caliceal Diverticuli
- Keywords
- Kidney stones, renal Calculi, Tic, Caliceal Diverticula
- Medical subject headings
- Kidney Calculi, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Caliceal DiverticuliProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Not described Receives: Procedure: Percutaneous Caliceal Diverticuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana Kidney Stone Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Investigators
- James E Lingeman, MD, Principal investigator, Methodist Urology, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169715
- Sponsor's protocol ID
- 03-019
- Status last verified
- Sep 2008
- First submitted
- 9 Sep 2005
- Last updated
- 18 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15758742
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Surgical Outcomes and Metabolic Findings in Patients With Stone-Bearing Calicial Diverticula
- ClinicalTrials.gov ID
- NCT00169715
- Acronym / sponsor ID
- 03-019
- Conditions
- Kidney Stones, Renal Calculi, Tic
- Keywords
- Kidney stones, renal Calculi, Tic, Caliceal Diverticula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Indiana Kidney Stone InstituteUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- Feb 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: Percutaneous Caliceal Diverticuli |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Male or female patients over the age of 18 with symptomatic caliceal diverticular stone(s) who have had or require percutaneous treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Caliceal DiverticuliStandard 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. | Procedure or surgery | A |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2008.
- Results publication: PubMed 15758742Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James E Lingeman, MD principal investigator
Methodist Urology, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Caliceal Diverticuli in people with Kidney Stones and Renal Calculi, run by Indiana Kidney Stone Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00169715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2008.