Mapping and Biopsy Study for Kidney Stones
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByJames Lingeman, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Indiana Kidney Stone Institute
No Placebo Group
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.
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.
12345What 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.
26789Is 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.
1011121314Eligibility 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.
+2 more
Exclusion Criteria
I have a bleeding disorder.
Poor general medical health
Inability or unwillingness to comply with post-surgical follow-up
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: cohortExperimental Treatment1 Intervention
Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
IU Health Methodist HospitalIndianapolis, IN
IU Health North HospitalIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana Kidney Stone InstituteLead Sponsor
Indiana University School of MedicineCollaborator
University of ChicagoCollaborator
References
The role of renal biopsy in small renal masses. [2020]Renal biopsy is being increasingly proposed as a diagnostic tool to characterize small renal masses (SRM). Indeed, the wide adoption of imaging in the diagnostic workup of many diseases had led to a substantial increased incidence of SRM (diameter ≤4 cm). While modern ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI) techniques have high sensitivity for detecting SRM, none is able to accurately and reliably characterize them in terms of histological features. This is currently of key importance in guiding clinical decision-making in some situations, and in these cases renal biopsy should be considered. In this review, we aim to summarize the technique, diagnostic performance, and predicting factors of nondiagnostic biopsy, as well as the future perspectives.
Protocol and establishment of a Queensland renal biopsy registry in Australia. [2021]Renal biopsy is often required to obtain information for diagnosis, management and prognosis of kidney disease that can be broadly classified into acute kidney injury (AKI) and chronic kidney disease (CKD). The most common conditions identified on renal biopsy are glomerulonephritis and tubulo-interstitial disorders. There is a paucity of information on management strategies and therapeutic outcomes in AKI and CKD patients. A renal biopsy registry will provide information on biopsy-proven kidney disorders to improve disease understanding and tracking, healthcare planning, patient care and outcomes.
Renal biopsy: update. [2022]The renal biopsy is an invaluable tool in the diagnosis, prognosis, and management of patients with kidney disease. As the success of the procedure is defined not only by the ability to obtain adequate tissue but also by the safety profile, significant advances which define risk factors and determine the optimal timing of observation after the percutaneous native renal biopsy merit discussion. Alternative methods of obtaining tissue, such as transvenous renal biopsies, have also been described, especially in patients with contraindications to the percutaneous method.
The Native Kidney Biopsy: Update and Evidence for Best Practice. [2022]The kidney biopsy is the gold standard in the diagnosis and management of many diseases. Since its introduction in the 1950s, advancements have been made in biopsy technique to improve diagnostic yield while minimizing complications. Here, we review kidney biopsy indications, techniques, and complications in the modern era. We also discuss patient populations in whom special consideration must be given when considering a kidney biopsy and the important role that the kidney biopsy plays in nephrology training. These data are presented to develop best practice strategies for this essential procedure.
A survey of current procedural practices of Australian and New Zealand nephrologists. [2018]The aim of this study was to describe the range and extent of current procedural practices of Nephrologists and trainees in Australia and New Zealand with a specific focus on renal biopsy. A web-based survey was constructed based on a 2009 pilot survey conducted by the authors. The survey was distributed by email. A total of 118 responses were received from 60 centers, including six pediatric centers; Nephrologists or trainees performed the following procedures: urine microscopy 36.4%; diagnostic ultrasound 10.2%; renal biopsy 93.2%; simple vascath insertion 64.4%; cuffed vascath insertion 22%; peritoneal catheter insertion 16.9%; fistula ultrasound 20.3%; and fistulography 5%. Trainees performed most renal biopsies (67.8% of respondents) and real-time ultrasound was the commonest technique (97%). The majority of respondents believe that renal biopsy is an essential skill for trainees (78.8%); 10-25 biopsies are required for trainee proficiency (59.3%); an online training module would assist in teaching renal biopsies (67.8%). Cuffed catheter insertion and fistulography were more often performed in nonmetropolitan than in metropolitan centers. Procedures are part of Australian and New Zealand Nephrology, including specialized procedures in a minority of centers. Vascular access procedures are more common in nonmetropolitan centers. Renal biopsy is an important skill, considered essential for trainees by most.
Safety profile of paediatric percutaneous ultrasonography-guided renal biopsies. [2010]Renal biopsy (RB) is a decisive diagnostic procedure for patients with renal disease. Our aim was to assess the safety of RB and the prevalence of associated clinical complications.
Bleeding complications of native kidney biopsy: a systematic review and meta-analysis. [2022]Kidney biopsy provides important information for nephrologists, but the risk of complications has not been systematically described.
Safety of Obtaining an Extra Biobank Kidney Biopsy Core. [2022]Kidney biopsy (KB) is the "gold standard" for the diagnosis of nephropathies and it is a diagnostic tool that presents a low rate of complications. Nowadays, biobank collections of renal tissue of patients with proven renal pathology are essential for research in nephrology. To provide enough tissue for the biobank collection, it is usually needed to obtain an extra kidney core at the time of kidney biopsy. The objective of our study is to evaluate the complications after KB and to analyze whether obtaining an extra core increases the risk of complications.
Study of glomerulonephritis evolution in Castilla-La Mancha (GLOMANCHA) between 1994 and 2008. [2017]Renal biopsy registries allow histopathological data to be collected to improve knowledge of different pathologies and their natural history.
Laparoscopic renal exploration and biopsy. [2019]A new and novel technique to obtain renal biopsy specimens using laparoscopy is presented. In some patients there are contraindications to obtaining biopsy material through standard percutaneous techniques. Open renal biopsy has been the procedure of choice in these patients. The laparoscopic approach can accomplish the same surgical objectives as open renal biopsy without the associated morbidity. This report discusses the indications, contraindications, materials, methods, and techniques associated with this new procedure.
[Diagnostic value and safety of percutaneous kidney biopsy in experience of one clinical center]. [2008]Percutaneous kidney biopsy is a widely applied diagnostic procedure providing with kidney tissue for microscopy.
Renal biopsy: a review from experience. [2004]A review of the use of percutaneous renal biopsy is presented, based on 12 years of personal experience. The place of biopsy today, and its role in diagnostic and investigative nephrology is discussed.
The renal biopsy. [2021]The first renal biopsy was carried out more than a century ago, but its widespread introduction into clinical use, beginning in the 1950s, helped develop nephrology into the powerful subspecialty of internal medicine that it is today. In the past 25 years, the use of the spring-loaded biopsy gun, in combination with newer visualization techniques, including ultrasound and computed axial tomography scanning, has led to greater tissue yield and to a much lower risk of complication. During this same time, our understanding of renal pathology has increased many fold. Correct fixation and processing of renal biopsy tissue is critical, and the laboratory must be skilled with renal biopsy light microscopy, immunohistochemistry, and transmission electron microscopy preparation.
Update on the Native Kidney Biopsy: Core Curriculum 2019. [2019]The kidney biopsy is an invaluable tool that has become the gold standard for the diagnosis of pathologic kidney diseases since the early 1950s. Throughout the years, immunohistologic and ultrastructural microscopy techniques have improved and provide more information on the cause and classification of kidney diseases than that available from simple light microscopy alone. Kidney biopsy has become a preferred method to obtain critical information that can be used in conjunction with serologic, urinary, and genetic testing to diagnose a variety of kidney diseases, both acute and chronic. The kidney biopsy procedure carries relatively low risk and yields substantial information. Potential complications include bleeding requiring transfusion, gross hematuria, arteriovenous fistula formation, and perinephric hematoma, among others. Percutaneous kidney biopsies are typically performed using real-time ultrasound or computed tomographic imaging. This Core Curriculum briefly outlines the history of the kidney biopsy, then discusses indications, complications, and specific procedural aspects.