Patients With Obstructive JaundicePhase 4NCT01090193
Human Kidney Histopathology in Obstructive Jaundice
A Phase 4 study testing Whipple operation,Hepaticojejunostomy in people with Patients With Obstructive Jaundice, run by Turkish Ministry of Health Izmir Teaching Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 86 years
- Conditions the study is for
- Patients With Obstructive Jaundice
- What is being tested?
- Whipple operation,Hepaticojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2009to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Teaching Hospital, Department of General Surgery
Izmir, 35290
About this study
Official title: Phase 4 Study :Human Kidney Histopathology in Acute Obstructive Jaundice: a Prospective Study
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.
Read the 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.
- Conditions
- Patients With Obstructive Jaundice
- Being tested
- Whipple operation,Hepaticojejunostomy
- Keywords
- Obstructive jaundice, kidney histopathology, lactulose
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whipple operation,HepaticojejunostomyProcedure or surgery
Also called Internal biliary drainage operations
Whipple operation, Hepaticojejunostomy
| Study group | Role | What they receive |
|---|---|---|
| obstructive jaundice | Other | Not described Receives: Procedure: Whipple operation,Hepaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Obstructive JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Ministry of Health Izmir Teaching Hospital
- Sponsor type
- Other government
- Investigators
- Adam Uslu, Assoc. Prof., Principal investigator, Izmir Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090193
- Sponsor's protocol ID
- BZYK01
- Status last verified
- Jan 2009
- First submitted
- 18 Mar 2010
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7620083
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study :Human Kidney Histopathology in Acute Obstructive Jaundice: a Prospective Study
- ClinicalTrials.gov ID
- NCT01090193
- Acronym / sponsor ID
- BZYK01
- Conditions
- Patients With Obstructive Jaundice
- Keywords
- Obstructive jaundice, kidney histopathology, lactulose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Turkish Ministry of Health Izmir Teaching HospitalOther government
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obstructive jaundice | Other | Procedure: Whipple operation,Hepaticojejunostomy |
Who may qualify
- Ages
- 26 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whipple operation,HepaticojejunostomyAlso: Internal biliary drainage operationsWhipple operation, Hepaticojejunostomy | Procedure or surgery | obstructive jaundice |
Primary outcome
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.
1 secondary outcome
Human kidney histopathology in acute obstructive jaundice: a prospective study
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2010.
- Results publication: PubMed 7620083Green 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.
Related trials for Patients With Obstructive Jaundice
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COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Not yet recruitingObservational study
Diagnostic Accuracy of Magnetic Resonance Cholangiopancreatography in Patients With Obstructive Jaundice
Obstructive Jaundice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Uslu, Assoc. Prof. principal investigator
Izmir Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Whipple operation,Hepaticojejunostomy in people with Patients With Obstructive Jaundice, run by Turkish Ministry of Health Izmir Teaching Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human kidney histopathology in acute obstructive jaundice: a prospective study (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2010.