Human Kidney Histopathology in Obstructive Jaundice
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|ClinicalTrials.gov Identifier: NCT01090193|
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : March 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Patients With Obstructive Jaundice||Procedure: Whipple operation,Hepaticojejunostomy||Phase 4|
Twenty consecutive patients with biliary obstruction were included. Fluid replacement, prevention of biliary sepsis and portal endotoxemia were mainstays of the perioperative treatment protocol. Fluid and electrolyte balance was maintained by twice daily body weight calculations, central venous pressure and mean arterial pressure (MAP) monitoring . Renal function was assessed by glomerular filtration rate estimation via MDRD-7 formula.
Kidney biopsy evaluation was focused on tubular changes, thrombotic microangiopathy, endothelial damage and peritubular capillary (PTC) dilatation with or without C4d staining. Fresh frozen sections were evaluated with immunoflourescence (IF)microscopy for glomerular IgG, IgA, IgM, C3, and C1q staining.
Despite those favourable figures, dilatation of peritubular venules and acute tubular necrosis were demonstrated synchronously in all cases. C4d staining in PTC and arterioles and thrombotic microangiopathy were entirely absent in the study group. Immune complex deposits in peritubular capillaries and in glomeruli were not detected. Three patients had isolated glomerular C4d deposition without accompanying thrombotic microangiopathy and IgG, IgA, IgM, C3, and C1q staining of glomerular capillaries in IF microscopy.
Discussion: This study is the first in the literature to address the histopathologic changes that occur in humans with short-term biliary obstruction. ATN and venous dilatation was observed in all biopsies, without exception, despite the maintenance of strict volume control in all patients. The adequacy of volume control may not be implicated in those results; rather a possible mechanism related to untrapped endotoxin in the gut lumen or systemic circulation might lead to prolonged peritubular capillary dilatation and hypoperfusion with synchronous acute tubular necrosis . Absolute recovery of renal function in all patients and the demonstration of solitary ATN with no microvascular-glomerular-interstitial inflammation or injury, suggests that the perioperative treatment regime in this study is fairly efficacious in short-term OJ.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 4 Study :Human Kidney Histopathology in Acute Obstructive Jaundice: a Prospective Study|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Procedure: Whipple operation,Hepaticojejunostomy
Whipple operation, Hepaticojejunostomy
Other Name: Internal biliary drainage operations
- Human kidney histopathology in acute obstructive jaundice: a prospective study [ Time Frame: 12 months ]the primary objective of this prospective study is to demonstrate the specific histopathologic changes in kidney parenchyme of patients undergoing surgery for short-term biliary tract obstruction.
- Human kidney histopathology in acute obstructive jaundice: a prospective study [ Time Frame: 12 months ]The secondary objective is to approve the feasibility of a standard perioperative medical treatment protocol, which has been implemented on a routine basis in our department over the last decade.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090193
|Izmir Teaching Hospital, Department of General Surgery|
|Izmir, Turkey, 35290|
|Principal Investigator:||Adam Uslu, Assoc. Prof.||Izmir Teaching Hospital|