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Human Kidney Histopathology in Obstructive Jaundice

Primary Purpose

Patients With Obstructive Jaundice

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Whipple operation,Hepaticojejunostomy
Sponsored by
Turkish Ministry of Health Izmir Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Patients With Obstructive Jaundice focused on measuring Obstructive jaundice, kidney histopathology, lactulose

Eligibility Criteria

26 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between January 2009 and January 2010, twenty consecutive patients with an equal distribution of biliary obstruction type (10 malignant and 10 benign) were included into the study.

Exclusion Criteria:

  • Patients over 60 years of age or those with a history of co-morbid cardiac disease were initially evaluated by echocardiography.
  • Those with an ejection fraction rate <50% and left ventricular end-diastolic diameter (LVDD) over 52 mm. were excluded from the study because of the already existing left ventricular dysfunction compromising the optimisation of fluid replacement.
  • Patients with a history and serologic evidence of acute/chronic parenchymal kidney or liver disease were also excluded.

Sites / Locations

  • Izmir Teaching Hospital, Department of General Surgery

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

obstructive jaundice

Arm Description

Outcomes

Primary Outcome Measures

Human kidney histopathology in acute obstructive jaundice: a prospective study
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.

Secondary Outcome Measures

Human kidney histopathology in acute obstructive jaundice: a prospective study
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.

Full Information

First Posted
March 18, 2010
Last Updated
March 18, 2010
Sponsor
Turkish Ministry of Health Izmir Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01090193
Brief Title
Human Kidney Histopathology in Obstructive Jaundice
Official Title
Phase 4 Study :Human Kidney Histopathology in Acute Obstructive Jaundice: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Turkish Ministry of Health Izmir Teaching Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction: Cholemia and bacterial translocation with portal endotoxemia are integral in the pathogenesis of obstructive jaundice (OJ). There is sufficient experimental data about hemodynamic and histopathologic consequences of OJ. On the contrary, pathologic information of renal changes in patients with OJ is still lacking. Therefore; the primary objective of this prospective study is to demonstrate the specific histopathologic changes in kidneys of patients with short-term biliary tract obstruction receiving a standard perioperative medical treatment protocol.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Obstructive Jaundice
Keywords
Obstructive jaundice, kidney histopathology, lactulose

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
obstructive jaundice
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Whipple operation,Hepaticojejunostomy
Other Intervention Name(s)
Internal biliary drainage operations
Intervention Description
Whipple operation, Hepaticojejunostomy
Primary Outcome Measure Information:
Title
Human kidney histopathology in acute obstructive jaundice: a prospective study
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Human kidney histopathology in acute obstructive jaundice: a prospective study
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between January 2009 and January 2010, twenty consecutive patients with an equal distribution of biliary obstruction type (10 malignant and 10 benign) were included into the study. Exclusion Criteria: Patients over 60 years of age or those with a history of co-morbid cardiac disease were initially evaluated by echocardiography. Those with an ejection fraction rate <50% and left ventricular end-diastolic diameter (LVDD) over 52 mm. were excluded from the study because of the already existing left ventricular dysfunction compromising the optimisation of fluid replacement. Patients with a history and serologic evidence of acute/chronic parenchymal kidney or liver disease were also excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Uslu, Assoc. Prof.
Organizational Affiliation
Izmir Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Teaching Hospital, Department of General Surgery
City
Izmir
ZIP/Postal Code
35290
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
7620083
Citation
Green J, Better OS. Systemic hypotension and renal failure in obstructive jaundice-mechanistic and therapeutic aspects. J Am Soc Nephrol. 1995 May;5(11):1853-71. doi: 10.1681/ASN.V5111853.
Results Reference
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Human Kidney Histopathology in Obstructive Jaundice

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