Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings for the Diagnosis of Either Acute Kidney Injury or Chronic Kidney Disease in Routine Practices (NEPHROCT)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier William Morey - Chalon sur Saône

About this trial

Kidney biopsy play a key role for the investigation of either acute kidney injury or chronic kidney disease. Despite possible complications due to the invasive nature of the biopsy, such procedure is still essential in a number of clinical situations to improve the diagnosis specificity of kidney disease, better inform about its prognosis and guide the management of a future treatment. Pursuing the idea to improve both performance and rapidity associated with the histopathological analysis of kidney biopsy, with a possible recourse to artificial intelligence-based renal pathology, the present study intends to assess the impact of direct histopathological examination of kidney biopsy with dynamic full-field optical coherence tomography in routine practices for the diagnosis of either acute kidney injury or chronic kidney disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients > 18 years of age with suspected acute kidney injury requiring biopsy in the nephrology department

patients > 18 years of age with suspected chronic kidney disease requiring biopsy in the nephrology department

Disqualifiers

inability to perform dynamic full-field optical coherence tomography observation at the moment of kidney biopsy

Trial population

patients \> 18 years of age with suspected acute kidney injury or chronic kidney disease requiring biopsy in the nephrology department

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Dynamic full-field optical coherence tomography analysis of kidney biopsy

    Other intervention

    Dynamic full-field optical coherence tomography analysis of kidney biopsy in the nephrology department before conventional histopathological analysis

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: NEPHROCT cohort1 intervention

Trial outcomes

Primary outcomes

1

Histopathological analysis of elementary lesions in nephropathology with dynamic full-field optical coherence tomography

Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and characterize common glomerular (abnormal / double contour of the glomerular basement membrane, focal segmental glomerulosclerosis, collapse of the glomerular tuft, proliferation of glomerular epithelial cells, endocapillary proliferation, mesangial expansion, necrosis and proliferation with mild increase in extracapillary cells...), vascular (hyaline change, fibrinoid change / necrosis, thrombosis, inflammation or necrosis of vascular walls, arteriosclerosis) and tubulointerstitial (acute tubular necrosis, cytoplasmic vacuolization, lipid inclusions in proximal / distal tubular cells, atrophy of tubules, edema, inflammation or interstitial fibrosis, cortical necrosis) lesions seen in kidney biopsy

Time frame
Outcome measure is assessed 15 days following kidney biopsy

Secondary outcomes

1

Histopathological analysis of healthy kidney biopsy with dynamic full-field optical coherence tomography

Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and characterize healthy glomerular (glomerular basement membrane, glomerular tuft, endothelial, epithelial, and mesangial cells, glomerular capsule and capsular space, glomerular capillaries), vascular (afferent and efferent arterioles, interlobular artery) and tubulointerstitial (proximal and distal tubular cells, normal cytoplasmic aspect) structures seen in kidney biopsy

Time frame
Outcome measure is assessed 15 days following kidney biopsy

Other outcomes

Sponsors and contacts

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Centre Hospitalier William Morey - Chalon sur Saône

Lead sponsor

Centre Hospitalier Universitaire Dijon

Collaborator