Mapping and Biopsy Study for Kidney Stones

Recruiting at 1 trial location

Overseen By Kim Smoot

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana Kidney Stone Institute

Disqualifiers: Poor health, Bleeding diathesis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

600 Participants Needed

Trial Summary

What is the purpose of this trial?

Kidney stones are very common. They affect 3-5% of the population in the United States. Many people are hospitalized for the treatment of kidney stones and some may die. Better understanding of what causes kidney stones is useful in both the treatment and prevention of kidney stones. However, exactly what causes kidney stones is unknown. The most common type of kidney stones contains calcium, which sometimes is attached to a part of the kidney important in producing the final urine, called the papilla. The investigators have noticed that persons who form kidney stones seem to have more papilla with stones attached. They propose to study these areas of the papilla, called Randall's plaques (named after their discoverer), in patients undergoing surgery for kidney stones.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the idea that Mapping and Biopsy Study for Kidney Stones is an effective treatment?

The available research shows that renal biopsy, a key part of the Mapping and Biopsy Study for Kidney Stones, is highly valued for its role in diagnosing and managing kidney diseases. It is considered the best method for understanding kidney conditions, as it provides detailed information that other imaging techniques cannot. This makes it an essential tool for doctors to make informed decisions about patient care. While the studies focus on kidney disease in general, they highlight the importance and effectiveness of biopsy in improving patient outcomes. ^{1 2 3 4 5}

What safety data exists for the kidney stone mapping and biopsy treatment?

The safety data for kidney biopsy, which is related to the treatment, indicates that it is a diagnostic tool with a low rate of complications. Studies have evaluated the safety of obtaining extra biopsy cores for biobanking and found that it does not significantly increase the risk of complications. Additionally, systematic reviews and registries have been established to track and analyze complications, primarily focusing on bleeding risks, to improve patient care and outcomes. ^{1 6 7 8 9}

Is the kidney biopsy procedure safe for humans?

Kidney biopsy, which involves taking a small sample of kidney tissue, is generally considered safe with a low rate of complications. Studies have evaluated its safety, including in children, and found it to be a reliable diagnostic tool with manageable risks. ^{1 6 7 8 9}

Is the treatment in the Mapping and Biopsy Study for Kidney Stones a promising treatment?

Yes, the treatment in the Mapping and Biopsy Study for Kidney Stones is promising because it uses a laparoscopic approach, which is less invasive than traditional open surgery. This method achieves the same goals with fewer complications, making it a valuable tool for diagnosing kidney issues. ^{10 11 12 13 14}

How does this treatment for kidney stones differ from other treatments?

This treatment involves a laparoscopic approach to obtain kidney biopsy specimens, which is less invasive than traditional open surgery and avoids the complications associated with percutaneous techniques. It offers a novel way to achieve the same objectives as open renal biopsy with reduced morbidity (risk of complications). ^{10 11 12 13 14}

Research Team

James Lingeman, MD

Principal Investigator

IU Health Physicians Urology

Eligibility Criteria

This trial is for people in good health who need surgery to remove kidney stones or treat other urologic conditions at Methodist Urology in Indianapolis, IN. Participants must be able to complete all study requirements and sign a consent form. Those with bleeding disorders, poor health, or unable to follow post-surgery instructions cannot join.

Inclusion Criteria

My health is good enough for surgery.

I have had a procedure to remove kidney stones using endoscopy or PERC.

I can complete all parts of the study.

Exclusion Criteria

I have a bleeding disorder.

Poor general medical health

Inability or unwillingness to comply with post-surgical follow-up

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Biopsy

Participants undergo percutaneous kidney stone removal and papillary biopsies are taken for analysis

1 day

1 visit (in-person)

Metabolic Studies

Approximately one month after surgery, metabolic studies are undertaken to review potential causes of stone formation

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Videotape for Mapping of Renal Anatomy and Papillary Biopsy

Trial Overview The study aims to better understand kidney stone causes by examining the papilla (kidney areas where stones attach) during surgery. It involves videotaping renal anatomy and taking papillary biopsies from patients undergoing stone removal procedures.

Participant Groups

Group I: cohort Experimental Treatment 1 Intervention

Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities

Who Is Running the Clinical Trial?

Indiana Kidney Stone Institute

Lead Sponsor

Trials

16

Recruited

6,200+

Indiana University School of Medicine

Collaborator

Trials

194

Recruited

181,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Findings from Research

The Queensland Renal Biopsy Registry (QRBR) was established to collect and analyze data on patients with biopsy-proven kidney diseases, aiming to enhance understanding and management of conditions like acute kidney injury (AKI) and chronic kidney disease (CKD).

By linking retrospective data from 2002-2018 with ongoing prospective data collection, the QRBR will generate annual reports to improve patient care and outcomes, ultimately aiding in healthcare planning and future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol and establishment of a Queensland renal biopsy registry in Australia. Burke, JP., Aljishi, M., Francis, L., et al.[2021]

Renal biopsy is becoming a valuable diagnostic tool for characterizing small renal masses (SRM), especially as the incidence of these masses has increased due to advanced imaging techniques.

While imaging methods like ultrasound, CT, and MRI can detect SRMs, they cannot reliably determine their histological features, making renal biopsy important for informed clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of renal biopsy in small renal masses. Burruni, R., Lhermitte, B., Cerantola, Y., et al.[2020]

Percutaneous renal biopsy is a safe and effective method for obtaining kidney tissue, with a recommended observation period of at least 24 hours post-procedure due to the risk of complications, primarily bleeding, occurring after 8 hours.

For patients with contraindications to the percutaneous method, alternative biopsy techniques such as open, laparoscopic, transurethral, or transvenous biopsies can be considered, but these should be performed by experienced physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal biopsy: update. Whittier, WL., Korbet, SM.[2022]

Kidney biopsy remains the gold standard for diagnosing and managing various kidney diseases, with advancements in techniques aimed at improving diagnostic accuracy and reducing complications.

The review emphasizes the importance of considering specific patient populations and highlights the role of kidney biopsy in nephrology training to ensure best practices in this essential procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Native Kidney Biopsy: Update and Evidence for Best Practice. Hogan, JJ., Mocanu, M., Berns, JS.[2022]

A survey of 118 nephrologists and trainees across 60 centers in Australia and New Zealand revealed that 93.2% perform renal biopsies, highlighting its importance in nephrology practice.

Most respondents (78.8%) believe renal biopsy is an essential skill for trainees, with 59.3% suggesting that 10-25 biopsies are necessary for proficiency, indicating a strong emphasis on hands-on training in this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of current procedural practices of Australian and New Zealand nephrologists. Ritchie, AG., Saunders, J., Baer, R., et al.[2018]

In a study of 221 patients undergoing kidney biopsy, the overall complication rate was low at 17.2%, with most being minor, indicating that kidney biopsy is a safe procedure for diagnosing nephropathies.

Obtaining an extra kidney core during the biopsy for research purposes does not increase the risk of complications, and having more cores (2 or 3) is associated with a lower risk compared to obtaining just one core.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Obtaining an Extra Biobank Kidney Biopsy Core. Bermejo, S., García-Carro, C., Mast, R., et al.[2022]

The GLOMANCHA study analyzed 941 renal biopsies over 14 years, revealing that lupus nephropathy and minimal change disease had the best renal prognoses, while rapidly progressive glomerulonephritis type 3 and focal segmental glomerulosclerosis had the worst outcomes.

Renal function at the time of biopsy was identified as an independent predictor of both renal survival and mortality, highlighting its importance in assessing patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of glomerulonephritis evolution in Castilla-La Mancha (GLOMANCHA) between 1994 and 2008. Conde Olasagasti, JL., Acevedo Ribó, M., Roca Muñoz, A., et al.[2017]

In a study of 166 renal biopsies performed on 164 children, no major complications were reported, indicating that renal biopsy is a safe procedure for pediatric patients.

Minor complications occurred in 23.5% of cases, with the most common being asymptomatic perirenal hematoma, suggesting that while some patients may experience minor issues, the overall safety profile of ultrasound-guided renal biopsy is favorable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of paediatric percutaneous ultrasonography-guided renal biopsies. Skalova, S., Rejtar, P.[2010]

A meta-analysis of 34 studies involving 9,474 kidney biopsies found that the risk of macroscopic hematuria is relatively low at 3.5%, and the need for erythrocyte transfusion is even lower at 0.9%.

Complication rates, particularly for transfusions, were higher when using larger 14-gauge needles and in patients with higher serum creatinine levels, suggesting that using smaller needles and careful patient selection may help reduce risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bleeding complications of native kidney biopsy: a systematic review and meta-analysis. Corapi, KM., Chen, JL., Balk, EM., et al.[2022]

Laparoscopic renal biopsy is a new technique that can safely obtain kidney tissue samples in patients who cannot undergo standard percutaneous biopsies, potentially reducing the need for more invasive open biopsies.

This method achieves the same surgical goals as open renal biopsy but with less associated morbidity, making it a promising alternative for kidney diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic renal exploration and biopsy. Squadrito, JF., Coletta, AV.[2019]

In a study of 119 pediatric patients, percutaneous kidney biopsy provided a histopathological diagnosis in 90% of cases, demonstrating its high diagnostic value for kidney tissue analysis.

While the procedure is generally effective, it carries a risk of serious complications, occurring in 4.2% of cases, including massive bleeding and nephrectomy, highlighting the importance of adhering to established guidelines for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic value and safety of percutaneous kidney biopsy in experience of one clinical center]. Adamczyk, P., Legaszewski, T., Banaszak, B., et al.[2008]

Percutaneous renal biopsy remains a crucial tool in diagnostic nephrology, providing valuable insights into kidney conditions based on 12 years of clinical experience.

The review highlights the evolving role of renal biopsy in guiding treatment decisions and improving patient outcomes in kidney disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal biopsy: a review from experience. Hocken, AG.[2004]

The introduction of spring-loaded biopsy guns and advanced imaging techniques like ultrasound and CT scans has significantly improved the safety and effectiveness of renal biopsies, resulting in higher tissue yield and lower complication rates.

Accurate diagnosis from renal biopsies relies heavily on skilled nephropathologists who can integrate detailed tissue analysis with clinical information, emphasizing the importance of proper laboratory methods in processing biopsy samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The renal biopsy. Walker, PD.[2021]

Kidney biopsy is the gold standard for diagnosing kidney diseases, providing critical information that enhances the accuracy of diagnoses when combined with other tests, such as serologic and genetic testing.

The procedure is relatively low-risk, with potential complications including bleeding and hematoma, but it remains a preferred method due to the substantial diagnostic information it yields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the Native Kidney Biopsy: Core Curriculum 2019. Luciano, RL., Moeckel, GW.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Protocol and establishment of a Queensland renal biopsy registry in Australia. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

The role of renal biopsy in small renal masses. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Renal biopsy: update. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Native Kidney Biopsy: Update and Evidence for Best Practice. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A survey of current procedural practices of Australian and New Zealand nephrologists. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Obtaining an Extra Biobank Kidney Biopsy Core. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Study of glomerulonephritis evolution in Castilla-La Mancha (GLOMANCHA) between 1994 and 2008. [2017]

8. India pubmed.ncbi.nlm.nih.gov

Safety profile of paediatric percutaneous ultrasonography-guided renal biopsies. [2010]

9. United States pubmed.ncbi.nlm.nih.gov

Bleeding complications of native kidney biopsy: a systematic review and meta-analysis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic renal exploration and biopsy. [2019]

11. Poland pubmed.ncbi.nlm.nih.gov

[Diagnostic value and safety of percutaneous kidney biopsy in experience of one clinical center]. [2008]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Renal biopsy: a review from experience. [2004]

13. United States pubmed.ncbi.nlm.nih.gov

The renal biopsy. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Update on the Native Kidney Biopsy: Core Curriculum 2019. [2019]