Mapping and Biopsy Study for Kidney Stones

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to uncover more about the causes of kidney stones, particularly those containing calcium. Researchers focus on the kidney's papilla, where stones often attach. Participants will undergo videotaping of their kidney anatomy (Videotape for Mapping of Renal Anatomy and Papillary Biopsy) and have biopsies taken from areas called Randall’s plaques during surgery. The trial seeks individuals scheduled for kidney stone surgery who do not have complicated health issues. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance understanding and prevention of 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 prior data suggests that this mapping and biopsy technique is safe for kidney stone patients?

Research has shown that the treatment for kidney stones, which involves video mapping of the kidney's structure and a small tissue sample (biopsy), is safe for participants. Studies have found that performing these biopsies during kidney stone removal does not cause major safety issues. In one study, 19 patients underwent these biopsies without any serious problems. This suggests that the treatment is generally well-tolerated. For those considering joining a trial with this treatment, current evidence supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel technique for mapping kidney stone anatomy and conducting biopsies. Unlike traditional imaging methods, this trial uses videotape to provide a detailed view of the renal anatomy, which helps in precisely targeting the areas for biopsy. This approach could improve the accuracy of kidney stone removal procedures and offer insights into the underlying causes of stone formation. By doing so, it has the potential to enhance treatment outcomes and reduce recurrence rates for patients undergoing percutaneous kidney stone removal.

What evidence suggests that this mapping and biopsy technique is effective for understanding kidney stones?

This study focuses on kidney stones, often composed of calcium and adhering to a part of the kidney called the papilla. Research has shown that individuals with kidney stones have more stones attached to these papilla areas, known as Randall's plaques. Understanding these plaques may improve the treatment and prevention of kidney stones. Participants in this trial will undergo videotaping for renal anatomy mapping and papillary biopsy to examine these areas and gather more information. By studying the kidney's structure, researchers aim to discover the causes of these painful stones and how to prevent them. ^{6 7 8}

Who Is on the Research Team?

James Lingeman, MD

Principal Investigator

IU Health Physicians Urology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. youtube.com youtube.com/watch?v=Ii84ZpYxgmE

Dr. Beatty Explains It All: Kidney Stones | Visible Body I'll be sharing how I use visible B human anatomy Atlas to quickly help patients visualize and understand their diagnosis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5880530/

Integration and utilization of modern technologies in ... A number of novel tools have been introduced over the past several years with the potential to improve our understanding of the aetiology of nephrolithiasis.

3. youtube.com youtube.com/watch?v=gZ6azCVNe20

Kidney Anatomy | UCLA Urology Kidney Stones: The Most PAINFUL Condition on Earth? Institute of Human Anatomy · 276K views ; The Kidney and Kidney Cancers | UCLA Urology. UCLA ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31407594/

Renal Papillary Mapping and Quantification of Randall's ... The purpose of this study is to investigate renal papillary abnormalities and quantify RP in pediatric CaOx SFs. Methods: Eight pediatric CaOx SFs underwent ...

5. researchgate.net researchgate.net/figure/Endoscopic-mapping-A-papillary-still-image-from-a-CaOx-stone-former-taken-by-video-is_fig7_236932165

Endoscopic mapping A papillary still image from a CaOx ... We performed a literature search to evaluate the safety of papillary tip biopsy and clinical insights gained from modern renal papillary investigations. A ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022534705628030

Endoscopic Renal Papillary Biopsies: A Tissue Retrieval ... Kuo and associates [111], however, reported the safety of performing renal papillary and cortical biopsies at the time of PNL in a series of 19 stone formers.

7. link.springer.com link.springer.com/article/10.1007/s00345-018-02616-3

Endoscopic observations as a tool to define underlying ... The aim of the study was to evaluate renal papillary appearance in kidney stone formers and to correlate papillary findings with stone type and patient ...

8. youtube.com youtube.com/watch?v=nCJm_KxwQOM

Medical Animation: Kidney Stone Disease This 3D medical animation explains kidney stone disease: how and why kidney stones form; major risk factors for development of stone disease ...